Difference between revisions of "Kiralp"
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:''' Double-blinded concealed randomised controlled trial with intention-to-treat.</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:''' Double-blinded concealed randomised controlled trial with intention-to-treat.</span> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study Patients:''' Diagnosed with CRPS about 1.5 months after trauma to upper limb and who had not received prior treatment. | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study Patients:''' Diagnosed with CRPS about 1.5 months after trauma to upper limb and who had not received prior treatment.</span> |
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:'''</span> | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N = 34; 34 analysed): Air at 2.4 ATA for 90 minutes daily for 15 sessions over three weeks, plus paracetamol 500mg three times daily.</span> |
| + | |||
| + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N = 37; 37 analysed): As above, but breathing 100% oxygen at 2.4 ATA</span> | ||
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| + | <span style="font-size:larger;"><span style="font-family: Arial, Helvetica, sans-serif;">'''The Evidence:'''</span></span> | ||
{| class="Table" style="border:solid windowtext 1.0pt" | {| class="Table" style="border:solid windowtext 1.0pt" | ||
|- | |- | ||
| − | | rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | rowspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Outcome at day 45</span></span>'''</span></p> |
| colspan="2" style="border:solid windowtext 1.0pt" | | | colspan="2" style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Air Group</span></span>'''</span> |
| − | | colspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | colspan="2" style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">HBOT Group</span></span>'''</span></p> |
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Difference</span></span>'''</span> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">95% CI</span></span>'''</span></p> |
|- | |- | ||
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Mean</span></span>'''</span> |
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">SD</span></span>'''</span> |
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Mean</span></span>'''</span> |
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">SD</span></span>'''</span> |
| style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" | | | style="border:solid windowtext 1.0pt; padding:.75pt .75pt .75pt .75pt" | | ||
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|- | |- | ||
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Visual analogue scale for pain (0 – 10)</span></span>'''</span> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">5.61</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">1.37</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">3.72</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">1.42</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">1.89</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family:">1.23 to 2.55</span></span></span></p> |
|- | |- | ||
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">wrist flexion (degrees)</span></span>'''</span> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">44.55</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">16.11</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">59.86</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">17.38</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">-15.31</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family:">-23.26 to -7.36</span></span></span></p> |
|- | |- | ||
| style="border:solid windowtext 1.0pt" | | | style="border:solid windowtext 1.0pt" | | ||
| − | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:">Wrist circumference (cm)</span></span>'''</span> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">18.2</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">0.72</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">16.98</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">0.71</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:">1.22</span></span></span></p> |
| − | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family: | + | | style="border:solid windowtext 1.0pt" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:13.0pt"><span style="font-family:">0.88 to 1.56</span></span></span></p> |
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<span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">4. No measure of the functional significance of these changes. It is not clear what the significance of 2 units of the VAS is, for example.</span> | <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">4. No measure of the functional significance of these changes. It is not clear what the significance of 2 units of the VAS is, for example.</span> | ||
| − | <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">5. Patients did appear well matched for severity prior to therapy.</span> <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">6. We have assumed no losses to follow-up, but not specifically stated in the paper.</span> <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">7. No mention of any confounders considered except age.</span> | + | <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">5. Patients did appear well matched for severity prior to therapy.</span> |
| + | |||
| + | <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">6. We have assumed no losses to follow-up, but not specifically stated in the paper.</span> | ||
| + | |||
| + | <span style="font-family: Arial, Helvetica, sans-serif; font-size: 120%;">7. No mention of any confounders considered except age.</span> | ||
| + | |||
| + | | ||
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by:''' Mike Bennett, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney ; Wednesday, 21 December 2005 Email: [[mailto:m.bennett@unsw.edu.au| m.bennett@unsw.edu.au]]</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by:''' Mike Bennett, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney ; Wednesday, 21 December 2005 Email: [[mailto:m.bennett@unsw.edu.au| m.bennett@unsw.edu.au]]</span> | ||
Revision as of 01:23, 17 August 2022
Hyperbaric oxygen therapy significantly reduced pain and swelling and increased wrist range of movement in patients with early CRPS.
Clinical Bottom Line:
| 1. There was a significant difference in favour of HBOT for pain, oedema and wrist flexion at day 45 after the start of the trial. 2. Functional significance for the patients is unknown. 3. No patient in either arm progressed to the atrophic stage of CRPS . |
Citation/s:1. Kiralp MZ, Yildiz S, Vural D, Kesin I, Ay H, Dursun H. Effectiveness of hyperbaric oxygen therapy in the treatment of complex regional pain syndrome. The Journal of International Medical Research 2004; 32:258-262.
Lead author's email: [mkiralp@hotmail.com]
Three-part Clinical Question: For patients with early post-traumatic complex regional pain syndrome (CRPS), does hyperbaric oxygenation result in a reduction in the severity of symptoms and signs of the syndrome?
Search Terms: Complex regional pain syndrome; reflex sympathetic dystrophy
The Study: Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Diagnosed with CRPS about 1.5 months after trauma to upper limb and who had not received prior treatment.
Control group (N = 34; 34 analysed): Air at 2.4 ATA for 90 minutes daily for 15 sessions over three weeks, plus paracetamol 500mg three times daily.
Experimental group (N = 37; 37 analysed): As above, but breathing 100% oxygen at 2.4 ATA
The Evidence:
Outcome at day 45 |
Air Group |
HBOT Group |
Difference |
95% CI | ||
|
Mean |
SD |
Mean |
SD |
|||
|
Visual analogue scale for pain (0 – 10) |
5.61 |
1.37 |
3.72 |
1.42 |
1.89 |
1.23 to 2.55 |
|
wrist flexion (degrees) |
44.55 |
16.11 |
59.86 |
17.38 |
-15.31 |
-23.26 to -7.36 |
|
Wrist circumference (cm) |
18.2 |
0.72 |
16.98 |
0.71 |
1.22 |
0.88 to 1.56 |
Comments:
1. All patients were probably young and relatively fit at entry.
2. The HBOT was given prior to other therapy and immediately on diagnosis (1.5 months after injury).
3. We have assumed all patients had CRPS affecting the hand.
4. No measure of the functional significance of these changes. It is not clear what the significance of 2 units of the VAS is, for example.
5. Patients did appear well matched for severity prior to therapy.
6. We have assumed no losses to follow-up, but not specifically stated in the paper.
7. No mention of any confounders considered except age.
Appraised by: Mike Bennett, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney ; Wednesday, 21 December 2005 Email: [m.bennett@unsw.edu.au]
Kill or Update By: June 2020
