NCT07050966

Brief Summary

This study is a randomized control trial and the purpose of this study is to investigate and compare the effects of Maitland's rotation mobilization and Mulligan's spinal mobilization with leg movement (SMWLM) on lumbar radiculopathy patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

July 15, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

May 28, 2025

Last Update Submit

July 2, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Lumbar Radiculopathy Pain

    It will be measured using Numeric Pain Rating Scale (NPRS). Subjects select a number ranging from 0-10 according to their intensity of pain where '0' indicates no pain while '10' indicates worst pain experienced.

    This protocol is given to the patient for a total of 6 sessions. NPRS is taken at the 1st, 3rd and 6th sessions respectively during the course of the treatment protocol.

  • Range of Motion

    Universal goniometer is used to measure Straight Leg Raise Range (SLR) of the patient. Patient is positioned in supine with the knee straight. Axis of goniometer is aligned with the greater trochanter of the femur; stationary arm is kept parallel to the femur and moving arm is aligned with long axis of femur. Patient is then asked to flex the hip joint, keeping the knee straight, to the maximum range without pain, subsequently aligning moving arm of the goniometer. Angle of flexion is then recorded from the goniometer and documented.

    This protocol is given to the patient for a total of 6 sessions. SLR Range is taken at the 1st, 3rd and 6th sessions respectively during the course of the treatment protocol.

  • Functional Status

    It is measured using Oswestry Disability Index Questionnaire (ODI-Q). The ODI-Q is a questionnaire used to assess an individual's ability to perform daily activities and functional tasks. It comprises of total 10 questions and patients rate their ability to perform each activity on a scale from 0 (unable to perform) to 5 (able to perform without difficulty). Each question has a maximum score of 5. The total maximum score is 50 which can change according to the number of total questions applicable to the respective patient. The obtained score is divided by the total score and multiplied by 100, giving a percentage as a result. Higher scores indicate better functional ability.

    This protocol is given to the patient for a total of 6 sessions. ODI Score is taken at the 1st, 3rd and 6th sessions respectively during the course of the treatment protocol.

Study Arms (2)

Group A

ACTIVE COMPARATOR

Group A: * Mulligan Mobilization Technique: Spinal Mobilization with Leg Movement (3 reps, 3 sets) * Neurodynamic Mobilization (1 set, 3 reps)

Procedure: Group A (Active Comparator) 1. Mulligan's Spinal Mobilization with Leg Movement (SMWLM) 2.Lower Limb Neurodynamic Mobilization

Group B

EXPERIMENTAL

Group B: Maitland Mobilization Technique; Lumbar rotation mobilization (3sets,3reps) Neurodynamic mobilization(1set,3reps)

Procedure: Group B (Experimental) 1. Maitland's Lumbar Rotation Mobilization 2.Lower Limb Neurodynamic Mobilization

Interventions

This group will receive Mulligan's Spinal Mobilization at the Lumbar Spine Region (L4-L5 level) along with Lower extremity movement (3 repetitions, 3 sets) followed by Neurodynamic Mobilization which will include slump technique (3 repetitions, 1 set). This protocol is given to the patient for a total of 6 sessions (1 session per day).

Group A

This group will receive Maitland's Lumbar Rotation Mobilization at the Lumbar Spine Region (L4-L5 level) along with Lower extremity movement (3 repetitions, 3 sets) followed by Neurodynamic Mobilization which will include slump technique (3 repetitions, 1 set).This protocol is given to the patient for a total of 6 sessions (1 session per day).

Group B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-65 years
  • Both Males and Females
  • Participants with a diagnosis of chronic (≥3 months) lumbar unilateral radiculopathy referred from Fauji Foundation Hospital, Rawalpindi
  • NPRS score of \> 5 and \< 8

You may not qualify if:

  • Diagnosis of other back conditions (e.g. failed back surgery syndrome, spondylosis, spondylolisthesis, and spinal stenosis, non-specific low back pain, and fracture)
  • Non ambulant/wheelchair-bound or having cauda equina syndrome
  • Patient taking anticoagulants
  • Pregnant Females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 3, 2025

Study Start

July 15, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Locations