CTRI

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CTRI Number

CTRI/2025/09/094992 [Registered on: 17/09/2025] Trial Registered Prospectively

Last Modified On:

16/09/2025

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

Needling, Spine pull and Nerve exercises in Low back pain

Scientific Title of Study

Combined effect of Dry Needling as an adjunct to Mechanical Traction and Neural Mobilizataion in subjects with Lumbar Radiculopathy: A RCT

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Santosh Metgud
Designation	Professor and Vice Principal
Affiliation	KAHER Institute of Physiotherapy
Address	Advanced physiotherapy center, room no. 39, Department of orthopedic manual therapy room no. 13, sagar floor, Belgaum KARNATAKA India Belgaum KARNATAKA 590010 India
Phone	9880088400
Fax
Email	santoshmetgud@klekipt.edu.in

Details of Contact Person
Scientific Query

Name	Dr Santosh Metgud
Designation	Professor and Vice Principal
Affiliation	KAHER Institute of Physiotherapy
Address	Advanced physiotherapy center, room no. 39, Department of orthopedic manual therapy room no. 13, sagar floor, Belgaum KARNATAKA India Belgaum KARNATAKA 590010 India
Phone	9880088400
Fax
Email	santoshmetgud@klekipt.edu.in

Details of Contact Person
Public Query

Name	Priyanka Naik
Designation	Post Graduate
Affiliation	KAHER Institute of Physiotherapy
Address	Advanced physiotherapy center, room no. 39, Department of orthopedic manual therapy room no. 13, sagar floor, Belgaum KARNATAKA India Belgaum KARNATAKA 590010 India
Phone	9606698749
Fax
Email	priyankanaik1510@gmail.com

Source of Monetary or Material Support

KLE Dr Prabhakar Kore hospital and research cente, Nehru Nagar, Belgavi-590010 India

Primary Sponsor

Name	Priyanka Niak
Address	Adavanced physiotherapy center, room no.39 Deparment of orthopedic manual therapy room no. 13, sagar floor, Belgaum karnataka- 590010
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Santosh Metgud	KAHER institute of physiotherapy	Advanced physiotherapy center, room no.39, Department of orthopaedic manual therapy room no.13, sagar floor, Belgaum Karnataka-590010 India Belgaum KARNATAKA	9880088400 santoshmetgud@klekipt.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Research and ethical committee KAHER institute of physiotherapy	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Lumbar Radiculopathy

Intervention / Comparator Agent

Type	Name	Details
Intervention	Dry needling and manual traction	Patients with lumbar radiculopathy will receive dry needling in prone lying, targeting lumbar paraspinal and gluteus medius trigger points. After aseptic cleaning, thin sterile needles (0.30x60 mm) are inserted with gentle movements to elicit a twitch response, retained for 2 minutes, and removed this is done twice weekly for 2 weeks. Mechanical traction is applied in supine Fowler position with stabilization straps, using intermittent pull (30-sec hold, 10-sec rest) for 15 minutes, starting at 25% and increasing up to 50% body weight, for 5 sessions over 2 weeks. Conventional treatment includes therapeutic exercises—pelvic bridge, back extension, cat–camel, bird–dog and partial curl-ups—each held 15–20 seconds for 10 reps × 3 sets daily, along with TENS for 20 minutes over the affected nerve root.2 days in a week for 2 weeks (Dry needling) 5 sessions for 2 weeks (Manual traction)
Comparator Agent	Dry needling and neural mobilization	Patients with lumbar radiculopathy will receive dry needling in prone lying, targeting lumbar paraspinal and gluteus medius trigger points. After aseptic cleaning, thin sterile needles (0.30x60 mm) are inserted with gentle movements to elicit a twitch response, retained for 2 minutes, and removed this is done twice weekly for 2 weeks.Neural mobilization includes NM of the femoral and sciatic nerves. For the femoral nerve, the participant lies in lateral decubitus with hip and knee flexed to 90°, while the therapist extends and adducts the top hip until lumbar lordosis increases and the foot touches the floor. Fifteen neural slides toward hip extension are performed, followed by spine and trunk flexion with a 6-second hold, also stimulating the lateral femoral cutaneous nerve. For the sciatic nerve, the participant sits with hands on the lumbar region maintaining lordosis, while the therapist extends the knee and flexes, adducts, and internally rotates the hip until maximum stretch is felt. Fifteen neural slides toward hip flexion are done, followed by spine and trunk flexion with a 6-second hold. This is combined with TENS and conventional treatment for 5 sessions over 2 weeks. 2 days in a week for 2 weeks (Dry needling) 5 sessions for 2 weeks (Neural Mobilization)

Inclusion Criteria

Age From	30.00 Year(s)
Age To	50.00 Year(s)
Gender	Both
Details	1.All genders between 30-50 years 2.Male and Female patients with lumbar radiculopathy and radiating to one leg. 3.Clinically diagnosed case of PIVD 4.Positive SLR and femoral test 5.Willing to participate

ExclusionCriteria

Details

1.History of spinal surgery
2.History of cancer
3.Fracture in the spine or pelvis
4.All red flags of needling
5.History of spinal canal stenosis
6.Pain that scored higher than 8 on the NPRS scale
7.Open wounds, skin diseases and hypersensitivity to metals
8.Pregnancy
9.Varicose veins
10.Subjects suffering from needle phobia
11.The participants with any coagulation disorder, the participants receiving anticoagulant therapy for any reason due to a potentially increased risk of hematoma following needling

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
1.Numeric pain rating scale 2.Modified Oswestry disability questionnaire 3.Modified Modified schobers test	All the outcome measures will be measured pre (Day 1 intervention) and post (Day 5 intervention)

Secondary Outcome

Outcome	TimePoints
Nil	Nil

Target Sample Size

Total Sample Size="34"
Sample Size from India="34"
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

N/A

Date of First Enrollment (India)

28/09/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

This randomized clinical trial investigates the combined effect of dry needling, spinal traction, and neural mobilization in patients with lumbar radiculopathy. Lumbar radiculopathy, commonly caused by disc herniation and nerve root compression, has a prevalence of 23.9% in India and 4–6% in the general population. The study will include 34 participants aged 30–50 years with radiating low back pain. Group A will receive dry needling with mechanical traction plus conventional therapy (core exercises and TENS). Group B will receive dry needling with neural mobilization plus conventional therapy. Dry needling targets lumbar paraspinal and gluteus medius trigger points to reduce pain and muscle tension. Mechanical traction helps decompress nerve roots, while neural mobilization improves femoral and sciatic nerve mobility. Conventional therapy includes stabilization exercises and TENS for pain relief. Outcome measures are pain intensity (NPRS), functional disability Modified Oswesrty disability questionnaire(MODQ), and lumbar mobility modified modified schober’s test (MMST).