NCT07641972

Brief Summary

Recruitment: Individuals with the lumbar spine radiculopathy diagnosis will undergo screening to determine their eligibility based on inclusion and exclusion criteria. Eligible participants will be asked for their informed consent. Enrollment: Participants will receive a unique identifying code to maintain confidentiality and be formally enrolled in the study upon obtaining informed consent. Following that, they will have baseline evaluations for outcome factors such as numeric pain rating scale, Oswestry disability index, and modified-modified Schober test. After completing the baseline evaluation, participants will be divided into two groups: Group A will receive the Mulligan's spinal mobilization with leg movement, while Group B will receive mechanical lumbar traction. Every participant will get treatment for four weeks, with three sessions per week. At the conclusion of the intervention period, a post-intervention assessment will be carried out.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2025Sep 2026

Study Start

First participant enrolled

June 2, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2026

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

June 8, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

lumber spine radiculopathySpinal Mobilization with Leg Movement.mulligan belt tractionMechanical traction on pain

Outcome Measures

Primary Outcomes (3)

  • numeric pain rating scale

    NUMERIC PAIN RATING SCALE (NPRS) The Numeric Rating Scale (NRS) is a validated tool used to measure pain intensity. Patients will be asked to rate their current pain severity on a scale from 0 to 10. Scoring can be obtained by calculating the mean score over a period of time or by tracking individual scores

    Baseline to 4 weeks

  • Lumbar Mobility

    OSWESTRY DISABILITY INDEX (ODI) The ODI is a ten-item questionnaire that assesses how back pain affects the patient's ability to perform daily activities of life (ADL). It is a reliable and valid self-reported questionnaire that lasts 5 min for the patient to complete the measure and a few minutes for the examiner to calculate the scores. Each item is scored from 0 to 5, and the summation of the ten scores is stated as a percentage of the maximum score; therefore, it ranges from 0 (no disability) to 100 (maximum disability)

    Baseline to 4 weeks

  • Functional Disability

    MODIFIED MODIFIED SCHOBER TEST (MMST) The Modified Modified Schober Test (MMST) is a clinical assessment of lumbar spine mobility where two marks are made on the patient's back-one at the midpoint between the posterior superior iliac spines (PSIS) and another 15 cm above it. The patient then bends forward maximally, and the increase in distance between the marks is measured; a normal increase is ≥5 cm, while reduced expansion suggests restricted lumbar flexion, as seen in conditions like ankylosing spondylitis, degenerative disc disease, or radiculopathy.

    Baseline to 4 weeks

Study Arms (2)

Spinal Mobilization With Leg Movement

EXPERIMENTAL

Spinal Mobilization With Leg Movement

Other: Spinal Mobilization With Leg Movement

conventional therapy

ACTIVE COMPARATOR

5 minutes conventional therapy with patient education will be given to participants of both groups according to the severity of their condition along with allocated intervention. This includes; directional preference exercises (e.g., McKenzie), core activation exercises, trunk and hip muscles strengthening and neurodynamic mobilization if nerve symptoms persist.

Other: Mechanical Lumbar Traction

Interventions

Group A: Mulligan's spinal mobilization with leg movement with Conventional Therapy Patient Position: The participants were positioned in a side-lying position on their unaffected side, close to the edge of the treatment table. Therapist Position: The affected leg was supported by therapist B and extended with a slight abduction of 10° at the hip and a knee flexion of 45°.Application of Technique: Therapist A applied and sustained a transverse glide of the spinous process toward the floor. The participants actively moved the leg into the SLR with therapist B's assistance. The L4 vertebra was selected if the participant had an L4/L5 lesion. Therapist A carefully assisted the participants to perform active SLR in a gliding position with the help of therapist B to avoid symptom recurrence during movement. If pain recurred, the participant was instructed to relax and hold the position for 3 s, and then return to the starting point(29).

Spinal Mobilization With Leg Movement

Group B: Mechanical Lumbar Traction with Conventional Therapy Patient Position: Patient position supine (lying on the back) with hips and knees flexed (pillows under the knees). However, prone (lying on the stomach) positioning can also be utilized, particularly when the patient experiences discomfort or when targeting anterior structures of the spine. Traction Technique: Mechanical lumbar traction is a technique that uses a machine to apply a controlled, distracting force to the lumbar spine. This can help relieve pressure on the spinal nerves, reduce muscle spasms, and improve spinal alignment. It's typically performed using a traction table and harnesses to gently pull the lower body away from the upper body. Duration: For lumbar traction, sessions usually range from 20 to 30 minutes, with a frequency of several times per week(30). Warm Up: 5minutes warm-up will be given before intervention to participants of both groups.

conventional therapy

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Middle Age 25 to 50 years
  • Both male and female of middle aged
  • Subacute or chronic lumbar radiculopathy lasting 4 to 12 weeks
  • Clinically diagnosed lumbar spine radiculopathy
  • Pain radiating from lumbar region to the leg in one or more dermatomal distribution of the lumbosacral nerve root
  • Moderate functional disability as indicated by Oswestry Disability Index (ODI) \>20%
  • Willing to participate and provide written informed consent.

You may not qualify if:

  • Acute pain (\<4 weeks)
  • Contraindications to manual therapy or traction such as spinal instability
  • significant musculoskeletal conditions, cerebrovascular accidents, psychiatric illness, or major systemic illness
  • Neurological compromised, other radicular pain (e.g., piriformis syndrome, diabetic radiculopathy, vascular impingement of the sciatic nerve)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Tazeem Afzal, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

June 2, 2025

Primary Completion (Estimated)

August 6, 2026

Study Completion (Estimated)

September 4, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

nill

Locations