RCT
ACE Report #10172

Single PRP injection does not significantly affect 10-week results of splinting for carpal tunnel


Study Type:Therapy
OE Level Evidence:2
Journal Level of Evidence:N/A

Safety and efficacy of platelet-rich plasma in treatment of carpal tunnel syndrome; a randomized controlled trial

BMC Musculoskelet Disord. 2018 Feb 13;19(1):49

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Synopsis

41 women with carpal tunnel syndrome were randomized to 8 weeks of nightly splinting with or without the addition of a single injection of platelet-rich plasma. Patients were followed up after 10 weeks from the beginning of treatment for results related to pain, outcome on the Boston Carpal Tunnel Questionnaire, and electrophysiological measures of peak latency of sensory nerve action potential (PL-SNAP) and onset latency of the compound muscle action potential (OL-CMAP). Results demonstrated no significant differences between the PRP group and the control group for any of the outcome measures assessed.

Publication Funding Details +
Funding:
Non-Industry funded
Sponsor:
Shahid Modarres Hospital, Physical Medicine and Rehabilitation Research center
Conflicts:
None disclosed

Risk of Bias

6/10

Reporting Criteria

18/21

Fragility Index

N/A

Was the allocation sequence adequately generated?

Was allocation adequately concealed?

Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?

Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?

Blinding Patients: Was knowledge of the allocated interventions adequately prevented?

Was loss to follow-up (missing outcome data) infrequent?

Are reports of the study free of suggestion of selective outcome reporting?

Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?

Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?

Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?

Yes = 1

Uncertain = 0.5

Not Relevant = 0

No = 0

The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.

4/4

Randomization

2/4

Outcome Measurements

4/4

Inclusion / Exclusion

4/4

Therapy Description

4/5

Statistics

Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65

The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.

Why was this study needed now?

The interest in platelet-rich plasma in the management of various orthopaedic and musculoskeletal surgeries and conditions has increased considerably in the past decades. Nonetheless, its efficacy in the management of individuals with carpal tunnel syndrome has not been previously tested.

What was the principal research question?

In women with carpal tunnel syndrome, does the addition of a single platelet-rich plasma injection to 8 weeks of splint wear have a significant effect on pain, function, or electrophysiological measures at 10 weeks after treatment initiation, as compared to 8 weeks of splint wear alone?

Study Characteristics -
Population:
41 women, 20-60 years of age, with carpal tunnel syndrome confirmed through clinical and electrophysiological tests. Inclusion criteria included only those with mild-to-moderate severity, as defined by the Stevens classification. All patients of both groups were prescribed a prefabricated wrist splint, with 5-deg wrist extension, to be worn nightly for 8 weeks.
Intervention:
PRP group: Patients were administered a single injection of platelet-rich plasma within the distal wrist crease ulnar to the palmaris longus tendon. PRP was prepared using a commercially available kit (Rooyagen kit; Arya Mabna Tashkis Corporation), using 10mL of blood that was treated with an anticoagulant, centrifuged for 12min at 1600rpm, then centrifuged for 7 min at 3500rpm for a final volume of approximately 1mL PRP. (n=21; Mean age: 51.20+/-9.82)
Comparison:
Control group: Patients were not administered an injection of platelet-rich plasma. (n=20; Mean age: 47.23+/-7.11)
Outcomes:
Outcomes included pain on a visual analog scale, function and symptoms scores on the Boston Carpal Tunnel Questionnaire (BCTQ), and peak latency of sensory nerve action potential (PL-SNAP) and onset latency of the compound muscle action potential (OL-CMAP) during the electrophysiological examination.
Methods:
RCT
Time:
Patients were assessed at 10 weeks after the beginning of treatment.

What were the important findings?

  • Reduction in VAS pain after 10 weeks did not significantly differ between the PRP group (-2.76+/-2.4) and the control group (-2.90+/-2.1) (p=0.845).
  • Reduction in BCTQ Symptom Severity score after 10 weeks did not significantly differ between the PRP group (-0.72+/-0.7) and the control group (-0.70+/-0.3) (p=0.922). Reduction in BCTQ Functional score after 10 weeks also did not significantly differ between the PRP group (-0.63+/-0.8) and the control group (-0.86+/-0.5) (p=0.289).
  • Reduction in PL-SNAP after 10 weeks did not significantly differ between the PRP group (-0.17+/-0.2) and the control group (-0.15+/-0.2) (p=0.820).
  • Reduction in OL-CMAP after 10 weeks did not significantly differ between the PRP group (-0.04+/-0.2) and the control group (-0.09+/-0.1) (p=0.410).

What should I remember most?

In the treatment of women with carpal tunnel syndrome, the addition of a single injection of platelet-rich plasma to 8 weeks of nightly splinting did not have a significant effect on change in pain, function, or electrophysiological measures over 10 weeks when compared to patients managed with nightly splinting alone.

How will this affect the care of my patients?

The results of this study suggest that a single platelet-rich plasma injection does not add any significant benefit to nightly splinting treatment for women with mild-to-moderate carpal tunnel syndrome. Given the small evidence base on the use of PRP in carpal tunnel syndrome treatment, additional randomized controlled trials should be considered.

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Anonymous 2018-04-26 8:34 PM

Orthopaedic Surgeon - Canada

plus de controles