| CTRI Number |
CTRI/2024/09/074133 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| 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
|
To check the effect of dry needling on hamstring for mechanical neck pain in long term sitting disomfort: A randomized controlled trial |
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Scientific Title of Study
|
Effect of dry needling on hamstring for mechanical neck pain in chronic seated postural strain: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayali Pushpak Patil |
| Designation |
Post graduate student |
| Affiliation |
KAHER Institute of Physiotherapy, Belagavi |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9324623690 |
| Fax |
|
| Email |
sayalip8.2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Professor and Head Of Department of Orthopaedic Manual Therapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Heggannavar |
| Designation |
Professor and Head Of Department of Orthopaedic Manual Therapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
KAHER Institute of Physiotherapy, Department of Orthopaedic Manual Therapy, OPD No. 39, Room no. 13, Nehru Nagar, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9945282896 |
| Fax |
|
| Email |
anandheggannavar@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Academy of Higher Education and Research, Dr. Prabhakar Kore Hospital, Nehru Nagar, Belgaum- 590010, India |
|
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Primary Sponsor
|
| Name |
Sayali Patil |
| Address |
KLES academy of Higher Education and Research, Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belgaum-590010, India |
| Type of Sponsor |
Other [Self sponsored project] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sayali Patil |
KLES Dr. Prabhakar Kore Hospital |
Sagar wards, OPD NO. 39, Physiotherapy Department, Belgaum, Karnataka
Belgaum
KARNATAKA |
9324623690
sayalip8.2000@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Institute of Physiotherapy |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mechanical Neck Pain |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY |
The conventional physiotherapy will include hot moist pack, neck isometrics, stretching and active cervical range of motion exercise.
It will be carried out for 6 sessions, 2 weeks. The duration will be 30mins for each session. |
| Intervention |
DRY NEEDLING |
Dry needling will be given on the hamstring muscle for mechanical neck pain in chronic seated postural strain individuals. The participants will also receive conventional physiotherapy that is hot moist pack, neck isometrics, stretching and active cervical range of motion exercise.
It will be carried out for 6 sessions, 2 weeks. The duration will be 30 mins - 40 mins for each session. |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged between 25 to 40 years
Consistently sitting for minimum of 6 hours a day for atleast 2 years.
Neck pain greater than 3 months withVAS greater than or equal to 3.
Hamstring tightness assessed with active knee extension test.
Partuicipants willing to participant. |
|
| ExclusionCriteria |
| Details |
Surgeries or fractures in past 6 months at the spine, hip , knee.
Taking medications for neck pain.
Orofacial pain and temporomandibular disorders, tension type headache, migraine.
Systemic diseases such as fibromyalgia, systemic erythematous lupus, and psoriatic arthritis.
Pregnancy, infection, sensitivity to metals, allergies and bleeding disorders. |
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Pain pressure threshold, neck range of motion and active knee extension test. |
Baseline and post 6 sessions. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue scale, Pain catastrophizing bscale and neck disability index. |
Baseline and post 6 sessions. |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2024 |
| Date of Study Completion (India) |
25/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Title: EFFECT OF DRY NEEDLING ON HAMSTRING FOR MECHANICAL NECK PAIN IN CHRONIC SEATED POSTURAL STRAIN: A RANDOMIZED CONTROLLED TRIAL
Introduction: "Work-related musculoskeletal disorders" (WRMSD) encompass injuries or diseases linked to work-related risk factors, also known as overuse or repetitive strain injuries. Among computer users, neck pain is prevalent, with 43.3% reporting work-related neck pain (WRNP). Prolonged forward bending and static posture can lead to neck pain, decreased job satisfaction, hypertension, and symptoms in the shoulders, lower back, and knees. Forward head posture straightens the cervical spine, causing discomfort in the trapezius area. Long sitting times also contribute to hamstring tightness, which is associated with chronic neck pain. Decreased muscle flexibility reduces range of motion and affects motor control, leading to tight muscles compressing blood vessels and impairing function. The superficial fascia, composed of loose connective tissue, contrasts with the deep fascia, which surrounds muscles, nerves, and organs with dense connective tissue. Fascia, now recognized as an active structure containing nerves, arteries, and contractile cells, plays a role in mechanical function and physiological activities. Muscle chains, like the superficial back line (SBL), connect fascia and muscles, aiding in postural support by maintaining upright extension and countering flexion. The hamstring, a major muscle in the SBL, can lead to posture issues like swayback or flat back when stressed. Dry needling, a technique for myofascial pain, uses a needle to target trigger points, stimulating pain suppression via A-delta fibers and encephalins.
Purpose: Studies on dry needling on the neck muscles for mechanical neck pain exist but there is limited research on the role of hamstring in individuals with mechanical neck pain. Hence the need arises.
Aim: To determine the effect of dry needling on hamstrings for mechanical neck pain in chronic seated postural strain. Objective: To evaluate and compare the effect of dry needling with conventional physiotherapy and conventional physiotherapy for neck pain, pain pressure threshold and range of motion using visual analogue scale, pain catastrophizing scale, algometer and goniometer respectively.
INCLUSION CRITERIA - Participants aged between 25-40 years.
• Participants willing to participate. • Consistently sitting for a minimum of 6 hours a day for at least 2 years • Neck pain > 3 months with VAS ≥ 3. • Hamstring tightness assessed with active knee extension test. EXCLUSION CRITERIA • Surgeries/fractures in the past 6 months at the spine, hip, knee • Taking medications for neck pain • Orofacial pain and temporomandibular disorders, tension type headache, migraine. • Systemic diseases such as fibromyalgia, systemic erythematous lupus, and psoriatic arthritis. • Pregnancy, infection, sensitivity to metals, allergies, bleeding disorders.
OUTCOME MEASURES vVisual Analogue Scale vPain Catastrophizing Scale vNeck Disability Index vPain Pressure Threshold vNeck Range of Motion vActive knee extension test: with a lag of 200 from full extension.
PROCEDURE Group 1: The participants will receive conventional physiotherapy for 30 mins. It will include hot moist pack for 10 mins , neck isometrics, stretching and active cervical range of motion exercise. They will receive 6 sessions and each session will be for 30-40 mins for 2 weeks.
Group 2: The participants will receive dry needling on hamstring muscle along with conventional physiotherapy . They will receive 6 sessions and each session will be for 30 mins for 2 weeks.
After 6 sessions pre and post data will be collected tabulated and analysed.
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