Carpal Tunnel SyndromeNCT06229249
Effectiveness of Carpal Ligament Self-myofascial Stretching in Carpal Tunnel Syndrome
A study testing Carpal ligament self-myofascial stretching and Conventional physical therapy in people with Carpal Tunnel Syndrome, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is common in the age group of 40-60 years. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Carpal ligament self-myofascial stretching and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 Nov 2022to 15 May 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with CTS between age group 30 - 60 years.
- Patients with stage I and II (mild) CTS, confirmed by nerve conduction study (EMG diagnosed by a medical professional).
- Patients who are able to read and understand English.
Who cannot join
- Presence of polyneuropathy.
- Consistent use of adaptive equipment, such as wheel chair or cane.
- Patients presenting with shoulder pathologies.
- Patients with other neurological or musculoskeletal conditions including Cervical radiculopathy, History of wrist and hand fractures, Upper extremity joint dislocations, Brachial plexus injuries, Cubital tunnel syndrome, Rheumatoid arthritis, De quervain's tenosynovitis, Cut injuries of hand.
- Patients who have underwent recent carpal tunnel release (within 1 year).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Carpal Ligament Self-myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage i and ii Carpal Tunnel Syndrome - a Comparative Study
Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is common in the age group of 40-60 years. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS-thirty-six subjects with stage I and II (mild) CTS were recruited. Thirty-six subjects who fulfilled the inclusion criteria were randomly assigned to the experimental group and control group, with 18 patients in each group. The experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy, while the control group received traditional physical therapy alone. The duration of the treatment was six weeks. The outcome measures used were the Boston Carpal Tunnel Questionnaire and the Visual Analogue Scale.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Carpal ligament self-myofascial stretching, Conventional physical therapy
- Keywords
- Myo-fascial stretching, Pain, Function
- Medical subject headings
- Carpal Tunnel Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carpal ligament self-myofascial stretchingOther
Carpal ligament self-myofascial stretching is a technique that involves applying pressure and stretching to the carpal ligaments and surrounding myofascial tissues of the wrist and hand. The objective is to release tension, improve flexibility, and alleviate discomfort or pain in the wrist and hand area.
Conventional physical therapyOther
In this technique, ultrasound therapy, nerve gliding exercise, tendon gliding exercise, and wrist splinting were performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The participants in this group received carpal ligament self-myofascial stretching along with conventional physical therapy. Receives: Other: Carpal ligament self-myofascial stretching |
| Control group | Active comparator | The participants in this group received conventional physical therapy. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Carpal Tunnel Questionnaire
The Boston carpal tunnel syndrome is a disease-specific patient-filled questionnaire, which comprises of two scales, a symptom severity scale (SSS) and a functional status scale (FSS). The symptom severity scale has 11 questions scored from 1 point (mildest) to 5 points (most severe) and the functional status scale has eight questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all). The greater the score, the more severe the severity of the disease.
Measured: 6 weeks
Visual Analogue Scale
The visual analogue scale consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (great pain). The greater the score, the more severe will be the pain.
Measured: 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start17 Nov 2022
- Primary completion10 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies 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
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masood Khan, King Saud University
- Investigators
- Masood Khan, MPTh, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229249
- Sponsor's protocol ID
- AWH/EC/01/2022
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Carpal Ligament Self-myofascial Stretching Over Conventional Physical Therapy on Reducing Pain and Improving Function in Patients With Stage i and ii Carpal Tunnel Syndrome - a Comparative Study
- ClinicalTrials.gov ID
- NCT06229249
- Acronym / sponsor ID
- AWH/EC/01/2022
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Myo-fascial stretching, Pain, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 29 Jan 2024 (actual)
- 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.
Carpal tunnel syndrome (CTS), also known as median mononeuropathy, occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. It is common in the age group of 40-60 years. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS-thirty-six subjects with stage I and II (mild) CTS were recruited. Thirty-six subjects who fulfilled the inclusion criteria were randomly assigned to the experimental group and control group, with 18 patients in each group. The experimental group received carpal ligament self-myofascial stretching along with conventional physical therapy, while the control group received traditional physical therapy alone. The duration of the treatment was six weeks. The outcome measures used were the Boston Carpal Tunnel Questionnaire and the Visual Analogue Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Carpal ligament self-myofascial stretchingThe participants in this group received carpal ligament self-myofascial stretching along with conventional physical therapy. |
| Control group | Active comparator | Other: Conventional physical therapyThe participants in this group received conventional physical therapy. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CTS between age group 30 - 60 years.
- Patients with stage I and II (mild) CTS, confirmed by nerve conduction study (EMG diagnosed by a medical professional).
- Patients who are able to read and understand English.
Key exclusion criteria (5 listed)
- Presence of polyneuropathy.
- Consistent use of adaptive equipment, such as wheel chair or cane.
- Patients presenting with shoulder pathologies.
- Patients with other neurological or musculoskeletal conditions including Cervical radiculopathy, History of wrist and hand fractures, Upper extremity joint dislocations, Brachial plexus injuries, Cubital tunnel syndrome, Rheumatoid arthritis, De quervain's tenosynovitis, Cut injuries of hand.
- Patients who have underwent recent carpal tunnel release (within 1 year).
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 |
|---|---|---|
| Carpal ligament self-myofascial stretchingCarpal ligament self-myofascial stretching is a technique that involves applying pressure and stretching to the carpal ligaments and surrounding myofascial tissues of the wrist and hand. The objective is to release tension, improve flexibility, and alleviate discomfort or pain in the wrist and hand area. | Other | Experimental group |
| Conventional physical therapyIn this technique, ultrasound therapy, nerve gliding exercise, tendon gliding exercise, and wrist splinting were performed. | Other | Control group |
Primary outcome
Boston Carpal Tunnel Questionnaire
Time frame: 6 weeks
The Boston carpal tunnel syndrome is a disease-specific patient-filled questionnaire, which comprises of two scales, a symptom severity scale (SSS) and a functional status scale (FSS). The symptom severity scale has 11 questions scored from 1 point (mildest) to 5 points (most severe) and the functional status scale has eight questions scored from 1 point (no difficulty with activity) to 5 points (cannot perform the activity at all). The greater the score, the more severe the severity of the disease.
Visual Analogue Scale
Time frame: 6 weeks.
The visual analogue scale consists of a 10-cm line, with the left extremity representing (the absence of pain) and the right extremity indicating (great pain). The greater the score, the more severe will be the pain.
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 29 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
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.
Masood Khan, MPTh principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carpal ligament self-myofascial stretching and Conventional physical therapy in people with Carpal Tunnel Syndrome, run by King Saud University at 1 site in Saudi Arabia.
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 3 inclusion and 5 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 29 Jan 2024. 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 Saudi Arabia. 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?
Boston Carpal Tunnel Questionnaire (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.