CTRI

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CTRI Number

CTRI/2025/07/091996 [Registered on: 30/07/2025] Trial Registered Prospectively

Last Modified On:

08/12/2025

Post Graduate Thesis

No

Type of Trial

Interventional

Type of Study

Physiotherapy (Not Including YOGA)

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Impact of Different Weights of Lumbar Traction on Leg Flexibility in Low Back Pain

Scientific Title of Study

Effects Of One-Fifth Versus One-Third of Bodyweight Lumbar Traction In Prone Lying Position On Straight Leg Raise Test - an Experimental study

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 Shivani Patil
Designation	Assistant Professor
Affiliation	KLE College of Physiotherapy Hubballi.
Address	KLE college of physiotherapy Hubballi Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway Dharwad KARNATAKA 580028 India
Phone	08369721874
Fax
Email	drshivanip24@kledeemeduniversity.edu.in

Details of Contact Person
Scientific Query

Name	Dr Shivani Patil
Designation	Assistant Professor
Affiliation	KLE College of Physiotherapy Hubballi.
Address	KLE college of physiotherapy Hubballi Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway KARNATAKA 580028 India
Phone	08369721874
Fax
Email	drshivanip24@kledeemeduniversity.edu.in

Details of Contact Person
Public Query

Name	Dr Shivani Patil
Designation	Assistant Professor
Affiliation	KLE College of Physiotherapy Hubballi.
Address	KLE college of physiotherapy Hubballi Gabbur,Near Kundgol Cross, Kotgondhunshi, Hubbali -Bengaluru Highway KARNATAKA 580028 India
Phone	08369721874
Fax
Email	drshivanip24@kledeemeduniversity.edu.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Shivani Patil
Address	KLE College of Physiotherapy, Hubballi
Type of Sponsor	Private medical college

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 Shivani Patil	KLE Cooperative Hospital	Shree Shakti Rd, New Hubli, Hubballi, Karnataka 580020, India Dharwad KARNATAKA	08369721874 drshivanip24@kledeemeduniversity.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
JGMM Medical College Institutional Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M258\|\|Other specified joint disorders,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Mechanic traction	Group A – Control Group (Conventional + Low-Intensity Mechanical Traction) Participants in Group A received mechanical traction at one-fifth of their body weight in the prone lying position, combined with conventional physiotherapy treatment. The mechanical traction was intermittent, with a 30-second hold and a 10-second rest, applied for 15 minutes. Prior to traction, conventional physiotherapy included: Hot pack to the low back for 10 minutes Transcutaneous Electrical Nerve Stimulation (TENS) to the low back for 10 minutes at a frequency of 0–100 Hz Stretching exercises: active hamstring and calf stretches, held for 10–15 seconds, performed three times a day Strengthening exercises: Pelvic bridging: 10 repetitions with 5–10 second hold (for paraspinal muscles) Abdominal crunches: 10 repetitions with 5–10 second hold (for abdominal muscles) Group B – Intervention Group (Conventional + High-Intensity Mechanical Traction) Participants in Group B received mechanical traction at one-third of their body weight in the prone lying position, along with the same conventional physiotherapy treatment protocol as Group A. The parameters for traction (mode: intermittent; 30-second hold, 10-second rest; 15 minutes total) and all conventional treatment modalities (hot pack, TENS, stretching, and strengthening exercises) were identical to those used in Group A.
Intervention	Mechanical Traction	Participants in Group B received mechanical traction applied at one-third of their body weight in the prone lying position, in addition to conventional physiotherapy treatment. This group was designed to investigate the effects of higher-intensity mechanical traction compared to the lower-intensity protocol used in Group A. The mechanical traction was administered in intermittent mode, with a traction-hold time of 30 seconds followed by a rest period of 10 seconds, for a total treatment duration of 15 minutes per session. This traction aimed to relieve pressure on spinal structures and reduce symptoms associated with mechanical low back pain. Prior to the application of mechanical traction, participants received a standardized conventional physiotherapy regimen, which included: Hot pack therapy applied to the low back region for 10 minutes to promote muscle relaxation and local circulation. Transcutaneous Electrical Nerve Stimulation (TENS) applied to the low back for 10 minutes, using a frequency range of 0–100 Hz to provide pain relief through sensory-level stimulation. Stretching exercises, specifically targeting the hamstring and calf muscles, performed actively by the patient. Each stretch was held for 10–15 seconds and repeated three times daily to improve flexibility and reduce muscle tightness. Strengthening exercises focused on the core and paraspinal muscles, consisting of: Pelvic bridging exercises, performed for 10 repetitions, with each repetition held for 5–10 seconds, targeting the paraspinal musculature. Abdominal crunches, also performed for 10 repetitions, with a 5–10 second hold, aimed at strengthening the abdominal muscles. The treatment protocol was delivered over a total of 10 sessions, with five sessions per week for a period of two consecutive weeks. The purpose of this intervention was to evaluate the added benefit of higher-intensity traction when combined with standard physiotherapy care.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients who met the diagnosis for PIVD on MRI scan who were having chronic LBP more than 6 months Both genders. Positive unilateral SLR test.

ExclusionCriteria

Details

Patients suffering from lower back pain due to neoplastic, inflammatory or
infections cause.
If urgent surgery is indicated.
If patient is having any history of previous spinal surgery
Pregnancy,Cord compress, spondylolisthesis, Ankylosingspondylitis, spinal fracture.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
ODI, SLR ROM, VAS	0 4 6 weeks

Secondary Outcome

Outcome	TimePoints
Nil

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="52"

Phase of Trial

Phase 1

Date of First Enrollment (India)

15/08/2025

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

15/08/2025

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Open to Recruitment

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

Brief Summary

This study investigates the effectiveness of lumbar mechanical traction at two different intensities—one-fifth vs. one-third of body weight—applied in the prone lying position in patients with prolapsed intervertebral disc (PIVD) of the lumbar spine. PIVD is a leading cause of low back pain (LBP), particularly prevalent in the Indian population, and is associated with nerve root compression, radiating pain, and functional impairment.

Although lumbar traction is a commonly used physiotherapy modality, no prior studies have compared different traction intensities in the prone position. This study aims to fill that gap by evaluating outcomes in terms of pain intensity, Oswestry Disability Index (ODI), and Straight Leg Raise (SLR) range of motion. Both groups receive conventional physiotherapy, with Group A receiving traction at one-fifth body weight and Group B at one-third.

The study highlights the need to determine whether higher-intensity traction offers superior clinical benefits in reducing pain and improving function in patients with lumbar PIVD.