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Carpal Tunnel SyndromeNCT01789645

Physical Therapy in Carpal Tunnel Syndrome

A study testing Conservative group and Surgical group in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Carpal Tunnel Syndrome
What is being tested?
Conservative group and Surgical group
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSpain
Study dates
20 Feb 2013to 28 Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pain and paresthesia in the median nerve distribution without extra-median nerve territory symptoms;
  • increasing symptoms during night;
  • Tinel sign;
  • Phalen sign;
  • self-reported hand strength deficits.
  • Deficits of sensory and motor nerve conduction of the median nerve according to standardized guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Academy of Physical Medicine and Rehabilitation

Who cannot join

  • if any sensory/motor deficit in ulnar or radial nerve was present;
  • previous interventions with surgery or steroid injections;
  • multiple diagnoses of the upper extremity (i.e., cervical radiculopathy, lateral epicondylalgia);
  • history of neck, shoulder or arm trauma;
  • history of a systemic disease causing CTS (e.g. diabetes mellitus, or thyroid disease);
  • history of systemic musculoskeletal conditions (e.g. rheumatoid arthritis, fibromyalgia);
  • if the patient was actively involved with or seeking litigation at the time of the study;
  • pregnancy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Rey Juan Carlos - Hospital Universitario Fundación Alcorcon

    Alcorcón, Madrid, 28922

Other trials in Spain

About this study

Official title: Efficacy of Conservative Versus Surgical Therapy for Carpal Tunnel Syndrome: a Randomised Clinical Trial

It is a randomized clinical trial comparing surgical and conservative (physical therapy) treatments for women with carpal tunnel syndrome (CTS). The purpose of the study is to determine the efficacy of physical therapy versus endoscopic surgery in pain and disability in women with carpal tunnel syndrome at medium and long-term follow-up periods. We hypothesized that proper physical therapy approach can be equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

Read the detailed description

Scientific evidence for the management of CTS has exhibited conflicting results. The Cochrane review concluded that surgical treatment relieves symptoms significantly better than splinting but further research is needed. A systematic review focused on physical therapy for the management of CTS included 6 studies and found weak to strong effect of neural gliding exercises. Recent studies have revealed complex nociceptive mechanisms involved in CTS which should be carefully considered during the management of these patients. Proper physical therapy interventions can modulate nociceptive processes found in CTS. We will perform a randomized clinical trial nested within a prospective cohort as our study design to determine if proper physical therapy approach targeted to modulate sensitization processes is equally effective than surgical intervention for improving pain and function in patients with carpal tunnel syndrome.

Being tested
Conservative group, Surgical group
Keywords
Carpal tunnel, Physical therapy, Surgery, Efficacy
Medical subject headings
Carpal Tunnel Syndrome, Median Neuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conservative groupOther

    The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.

  • Surgical groupProcedure or surgery

    The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.

Study groups in NCT01789645
Study groupRoleWhat they receive
Conservative groupExperimentalThe conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.
Receives: Other: Conservative group
Surgical groupActive comparatorThe surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Receives: Procedure: Surgical group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the intensity of pain symptoms between baseline and follow-up periods

    A 10-cm Numerical Pain Rating Scale(NPRS; 0: no pain, 10: maximum pain) will be used to assess current level of hand pain, and worst level of hand pain experienced in the preceding week.

    Measured: Baseline and 1, 3, 6 and 12 months after the intervention

Secondary outcomes (3)

  1. Changes in patients self-perceived improvement between baseline and follow-up periods

    Patients self-perceived improvement will be assessed using a Global Rating of Change (GROC) consisting of a 15-point scale ranging from -7 (a very great deal worse) to +7 (a very great deal better). Descriptors of worsening or improving are assigned with values ranging from -1 to -7 and +1 to +7, respectively.

    Measured: Baseline and 1, 3, 6 and 12 months after the intervention

  2. Changes in function between baseline and follow-up periods

    The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.

    Measured: Baseline, and 1, 3, 6 and 12 months after intervention

  3. Changes in severity of the symptoms between baseline and follow-up periods

    The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used. This questionnaire evaluates two domains: a) the functional status scale assesses ability to perform 8 common hand-related tasks; b) the symptom severity scale includes 11 items assessing pain severity, numbness, and weakness at night and during the day. Each question is answered on a 5 point scale (1: no complaint; 5: severe complaint), with higher scores indicating greater severity.

    Measured: Baseline, and 1, 3, 6 and 12 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2013 (estimated)
  2. Study start20 Feb 2013
  3. Primary completion25 Jan 2014
  4. Study completion28 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01789645
Sponsor's protocol ID
PI01223
Status last verified
Aug 2019
First submitted
6 Feb 2013
Last updated
15 Aug 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Lopez-de-Uralde-Villanueva I, Fernandez-de-Las-Penas C, Cleland JA, Cook C, de-la-Llave-Rincon AI, Valera-Calero JA, Plaza-Manzano G. Minimal Clinically Important Differences in Hand Pain Intensity (Numerical Pain Rate Scale) and Related-Function (Boston Carpal Tunnel Questionnaire) in Women With Carpal Tunnel Syndrome. Arch Phys Med Rehabil. 2024 Jan;105(1):67-74. doi: 10.1016/j.apmr.2023.07.018. Epub 2023 Aug 13.

    PubMed 37582474

  • Liew BXW, de-la-Llave-Rincon AI, Scutari M, Arias-Buria JL, Cook CE, Cleland J, Fernandez-de-Las-Penas C. Do Short-Term Effects Predict Long-Term Improvements in Women Who Receive Manual Therapy or Surgery for Carpal Tunnel Syndrome? A Bayesian Network Analysis of a Randomized Clinical Trial. Phys Ther. 2022 Apr 1;102(4):pzac015. doi: 10.1093/ptj/pzac015.

    PubMed 35194646

  • Fernandez-de-Las-Penas C, Arias-Buria JL, Cleland JA, Pareja JA, Plaza-Manzano G, Ortega-Santiago R. Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial. Phys Ther. 2020 Oct 30;100(11):1987-1996. doi: 10.1093/ptj/pzaa150.

    PubMed 32766779

  • Fernandez-de-Las Penas C, Ortega-Santiago R, de la Llave-Rincon AI, Martinez-Perez A, Fahandezh-Saddi Diaz H, Martinez-Martin J, Pareja JA, Cuadrado-Perez ML. Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial. J Pain. 2015 Nov;16(11):1087-94. doi: 10.1016/j.jpain.2015.07.012. Epub 2015 Aug 15.

    PubMed 26281946

Questions about this trial

What is this clinical trial studying?

A study testing Conservative group and Surgical group in people with Carpal Tunnel Syndrome, run by Universidad Rey Juan Carlos at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the intensity of pain symptoms between baseline and follow-up periods (time frame: Baseline and 1, 3, 6 and 12 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01789645, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.

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