| CTRI Number |
CTRI/2024/12/077884 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
07/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Physiotherapeutic management in Carpal Tunnel Syndrome. |
|
Scientific Title of Study
|
Effectiveness of Median Nerve Mobilization versus Dry Needling in Carpal Tunnel Syndrome among Housemaids and Housewives
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Priya |
| Designation |
Research Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy,
Amity Institute of Health Allied Sciences,
Amity University,
F1 LGF, Sector 125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9950052378 |
| Fax |
|
| Email |
mandippriya9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy,
Amity Institute of Health Allied Sciences,
Amity University,
F1 LGF, Sector 125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy,
Amity Institute of Health Allied Sciences,
Amity University,
F1 LGF, Sector 125, Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh.
PIN - 201313
India |
|
|
Primary Sponsor
|
| Name |
Nikita Priya |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences,
Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjib Kumar Das |
Department of Physiotherapy, Amity Institute of Health Allied Sciences,
Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikita Priya |
Amity Institute of Health Allied Sciences |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, F1 LGF, Sector 125, Noida, Uttar Pradesh
PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH |
9950052378
mandippriya9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G560||Carpal tunnel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry Needling |
Position: The patient lies supine with the forearm supinated and supported by a pillow for comfort. The therapist, seated beside the patient, ensures clear access to the forearm and hand.
Preparation and procedure: The forearm and thenar muscles are cleansed with an alcohol swab for sanitization. A 13mm needle is selected for targeting the thenar muscles. The needle is carefully inserted into the muscle bands, ensuring that insertion avoids the carpal tunnel. Gentle manipulation of the needle is performed to elicit twitch responses and the needle is left in place for 5 to 10 minutes. The needle is then slowly removed, the treated area is gently massaged, and ice is applied if irritation or discomfort occurs.
Frequency - 2 sessions per week for 4 weeks. |
| Comparator Agent |
Median Nerve Mobilisation |
Position: The patient is seated with the shoulder slightly abducted and the forearm supinated, while the therapist stands or sits beside the patient to provide support and guidance.
Preparation and procedure: In the starting position, the patient’s arm is at their side, elbow flexed at 90 degrees, wrist neutral, and fingers relaxed. The therapist then guides the patient to extend the elbow while maintaining forearm supination. Next, the wrist and fingers are slowly extended, and the position is held for 5 to 10 seconds before returning to the starting position. This stretch-relax cycle is repeated, with a one-minute rest between repetitions. The patient then laterally flexes their neck away from the treated side to enhance the stretch along the nerve pathway according to their tolerance level.
Frequency - 3 sessions per week for 4 weeks
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Participants must have a clinical diagnosis of CTS confirmed by a healthcare professional (mild to moderate CTS)
2. Participants should be between 18 and 50 years old.
3. Must be housemaids or housewives engaged in regular household activities (involving repetitive wrist movements).
4. Participants should have been experiencing symptoms of CTS for at least 3 months.
5. Participants must be willing to provide informed consent and adhere to the study protocol, including attending all treatment sessions and follow-up evaluations.
|
|
| ExclusionCriteria |
| Details |
1. Participants who have undergone surgical intervention for CTS (e.g., carpal tunnel release surgery) are excluded.
2. Participants who were involved in any other economically productive occupation other than housework (industries, home-based workshop, etc).
3. Presence of other neurological conditions that could interfere with the study results (e.g., cervical radiculopathy, polyneuropathy).
4. Participants with severe comorbidities (e.g., rheumatoid arthritis, thyroid, uncontrolled diabetes)
5. Pregnant women are excluded due to potential changes in fluid dynamics and risk factors.
6. Participants who have received corticosteroid injections for CTS within the last 3 months
7. Participants with contraindications to dry needling, such as bleeding disorders, needle phobia, or local skin infections, are excluded.
8. Participants with severe CTS, as indicated by significant muscle atrophy, loss of dexterity, or non-responsiveness to conservative treatments, are excluded.
9. Participants currently undergoing other treatments for CTS, such as alternative physiotherapy techniques, massage, ultrasound etc or participants who have already received physiotherapeutic treatment for CTS within the last 6 months.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain level, Symptom severity, Functional status |
1. Baseline assessment - before the intervention
2. Follow-up assessment - after every session
3. Final assessment- after 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Carpal Tunnel Syndrome or CTS the most common entrapment neuropathy, arises from median nerve compression causing pain, numbness and tingling. It affects about 8 per cent of adults and is 2 to 3 times more common in women. Repetitive tasks such as household chores increase the risk, particularly among housemaids and housewives. Physiotherapy plays a key role in managing CTS by alleviating pain, improving wrist function and preventing its progression. A comprehensive bibliometric analysis was performed to identify the most effective interventions for managing CTS in these women revealing that median nerve mobilization was extensively studied while dry needling emerged as a promising treatment option.
Need of the Study Since there is a high incidence of CTS due to household chores among housemaids and housewives, it is important to explore potential interventions. Although both median nerve mobilization and dry needling have been used to treat CTS, there is limited research comparing their effectiveness, particularly in populations engaged in domestic work. This study seeks to determine which intervention is more effective in alleviating symptoms and improving the function of housemaids and housewives. Aim The study aims to assess and compare the efficacy of Median Nerve Mobilisation and Dry Needling in the treatment of Carpal Tunnel Syndrome resulting from household chores among housemaids and housewives.
Objectives
- To evaluate the effectiveness of Median Nerve Mobilisation in reducing pain and improving function in patients with Carpal Tunnel Syndrome.
- To assess the effectiveness of Dry Needling in alleviating symptoms of Carpal Tunnel Syndrome in the target population.
- To compare the overall outcomes of Median Nerve Mobilisation and Dry Needling in terms of pain relief and functional improvement.
- To explore the prevailing intervention for Carpal Tunnel Syndrome.
Null Hypothesis • There is no significant improvement of Dry Needling compared to Median nerve mobilisation in the treatment of Carpal Tunnel Syndrome among housemaids and housewives engaged in household activities.
• Dry needling has no significant efficacy on carpal tunnel syndrome among housemaids and housewives engaged in household activities.
• Median nerve mobilisation has no significant efficacy on carpal tunnel syndrome among housemaids and housewives engaged in household activities. Alternate Hypothesis • There is a significant improvement of Dry needling compared to Median Nerve Mobilisation in the treatment of Carpal Tunnel Syndrome among housemaids and housewives engaged in household activities.
• Dry needling is significantly more effective for carpal tunnel syndrome among housemaids and housewives engaged in household activities compared to Median nerve mobilisation.
• Median nerve mobilisation is significantly more effective for carpal tunnel syndrome among housemaids and housewives engaged in household activities compared to Dry needling.
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