Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT07641972
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction in Lumbar Spine Radiculopathy.
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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
25 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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. Randomization: Random allocation of participants into the two groups, Group A and Group B, will be performed by a lottery method. The participants of Group A will be managed by Mulligan's spinal mobilization with leg movement while in Group B, participants will receive mechanical lumbar traction. The physiotherapists will provide both interventions during a specified period. Blindness: A single blinded study in which patients will be blinded.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Treatment and study plan
Spinal Mobilization With Leg Movement
OtherGroup 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).
Mechanical Lumbar Traction
OtherGroup 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.
Primary outcomes
-
numeric pain rating scale
Time frame: Baseline to 4 weeks
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
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Lumbar Mobility
Time frame: Baseline to 4 weeks
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)
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Functional Disability
Time frame: Baseline to 4 weeks
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.
Sponsors and collaborators
Lead sponsor
Riphah International University
Other
Registry information
Official study title
Comparative Effects of Spinal Mobilization With Leg Movement, and Mechanical Traction on Pain, Lumbar Mobility and Functional Disability in Patients With Lumbar Spine Radiculopathy.
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jun 11, 2026
- Registry last updated
- Jun 11, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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