Carpal Tunnel SyndromesNCT02233660
The Role of the Cervical Spine in Carpal Tunnel Syndrome
A study testing Physical Therapy Group and Surgical Group in people with Carpal Tunnel Syndromes, run by Universidad Rey Juan Carlos at 2 sites in Spain.
Trial summary
This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Carpal Tunnel Syndromes
- What is being tested?
- Physical Therapy Group and Surgical Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSpain
- Study dates
- Sep 2014to Mar 2016
- 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
- Positive Tinel sign,
- Positive Phalen sign,
- Symptoms had to have persisted for at least 6 months
- Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
Who cannot join
- Any sensory/motor deficit related to the ulnar or radial nerve;
- Older than 65 years of age;
- Previous surgical intervention, steroid injections or physical therapy intervention
- Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- History of neck, shoulder, or upper limb trauma (whiplash);
- History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
- History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Fundación Alcorcon
Alcorcón, Madrid, 28922
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
About this study
Official title: Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.
Read the detailed description
There is some evidence suggesting that CTS is associated with restricted cervical range of motion and deficits in pinch grip force. In fact, restricted cervical range of motion and deficits in pinch grip force seems to be independent of electro-diagnostic findings. These findings would be associated with the proposed "double crush syndrome" theory. However no longitudinal studies have been conducted. Further it has been demonstrated that hand function is associated to deficits in these outcomes. Since previous studies support the use of physical therapy and surgical interventions for the management of function in these patients, the aim of this study is to conduct a randomized clinical trial to determine if changes in hand function are related to changes in active cervical range of motion and pinch grip force after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or endoscopic surgery in women with CTS.
- Conditions
- Carpal Tunnel Syndromes
- Being tested
- Physical Therapy Group, Surgical Group
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy GroupOther
The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
Surgical GroupProcedure or surgery
The surgical group will receive a 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 group | Role | What they receive |
|---|---|---|
| Physical Therapy Group. | Experimental | The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week. Receives: Other: Physical Therapy Group |
| Surgical Group | Active comparator | The surgical group will receive a 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.
Changes in hand function between baseline and follow-up periods
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) 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. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
Measured: Baseline and 1, 3, 6 and 12 months after the intervention
Secondary outcomes (2)
Changes in active cervical range of motion between baseline and follow-up periods
A cervical range of motion (CROM) device will be used to assess cervical range of motion in a single direction: flexion, extension, lateral flexion toward or away from the side of the CTS, and rotation toward or away from the side of the CTS. For patients with unilateral symptoms, sides are classified as affected or unaffected whereas in those with bilateral symptoms, the most painful side will be considered as the affected side and the less painful side as the unaffected side.
Measured: Baseline and 1, 3, 6 and 12 months after the intervention
Changes in pinch grip force between baseline and follow-up periods
Pinch grip force between the tip of the thumb with the tip of the index or the little finger will be measured with a pinch grip dynamometer
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.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233660
- Sponsor's protocol ID
- HUFA PI -12/0023
- Status last verified
- Mar 2016
- First submitted
- 3 Sep 2014
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez-de-Las-Penas C, Cleland J, Palacios-Cena M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3.
PubMed 28158963
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Function, Cervical Range of Motion and Pinch Grip Force After Physical Therapy in Carpal Tunnel Syndrome: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02233660
- Acronym / sponsor ID
- HUFA PI -12/0023
- Conditions
- Carpal Tunnel Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón
- Study start
- Sep 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.
Detailed description
There is some evidence suggesting that CTS is associated with restricted cervical range of motion and deficits in pinch grip force. In fact, restricted cervical range of motion and deficits in pinch grip force seems to be independent of electro-diagnostic findings. These findings would be associated with the proposed "double crush syndrome" theory. However no longitudinal studies have been conducted. Further it has been demonstrated that hand function is associated to deficits in these outcomes. Since previous studies support the use of physical therapy and surgical interventions for the management of function in these patients, the aim of this study is to conduct a randomized clinical trial to determine if changes in hand function are related to changes in active cervical range of motion and pinch grip force after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or endoscopic surgery in women with CTS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Group. | Experimental | Other: Physical Therapy GroupThe physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week. |
| Surgical Group | Active comparator | Procedure: Surgical GroupThe surgical group will receive a 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pain and paresthesia in the median nerve distribution
- Positive Tinel sign,
- Positive Phalen sign,
- Symptoms had to have persisted for at least 6 months
- Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy
Key exclusion criteria (8 listed)
- Any sensory/motor deficit related to the ulnar or radial nerve;
- Older than 65 years of age;
- Previous surgical intervention, steroid injections or physical therapy intervention
- Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
- History of neck, shoulder, or upper limb trauma (whiplash);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy GroupThe physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week. | Other | Physical Therapy Group. |
| Surgical GroupThe surgical group will receive a 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. | Procedure or surgery | Surgical Group |
Primary outcome
Changes in hand function between baseline and follow-up periods
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention
The Spanish version of the Boston Carpal Tunnel Questionnaire (BCTQ) will be used to assess function. This questionnaire evaluates 2 domains: 1) the functional status scale assesses ability to perform 8 common hand-related tasks; and, 2) 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. In the current study the score of the functional status scale of this questionnaire will be used as the main outcome.
2 secondary outcomes
Changes in active cervical range of motion between baseline and follow-up periods
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention
Changes in pinch grip force between baseline and follow-up periods
Time frame: Baseline and 1, 3, 6 and 12 months after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
- Derived from this study: PubMed 28158963Fernandez-de-Las-Penas C, Cleland J, Palacios-Cena M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy Group and Surgical Group in people with Carpal Tunnel Syndromes, run by Universidad Rey Juan Carlos at 2 sites 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 5 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 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 hand function 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 NCT02233660, which also lists 1 linked publication.
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 Mar 2016.