NCT05955781

Brief Summary

This study will be a Randomized Control Trial in which Both Genders with Age between 20 to 50 Years who had diagnosed with lumbar radiculopathy will be recriuted in to two groups.group A will be recieving spinal mobilzation with leg movement along with TENS \& hot pack.whie group B will be given only spinal mobilization with TENS \& hot pack.before and after the introduction of interventions pain,disabaility,speed of gait,cadence and SLR will be checked before and after the treatment

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 9, 2023

Last Update Submit

July 19, 2023

Conditions

Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • pain severity

    Pain will be measured using Numeric Pain Rating Scale which is an eleven point scale scored from 0 indicating no pain and 10 indicating worst pain

    2 weeks

Secondary Outcomes (3)

  • Straight leg raise

    2 weeks

  • Lumbar Disability

    2 weeks

  • Cadence

    2 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Spinal Mobilization with Leg Movement (SMWLM) will be given as intervention to experimental group. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.

Procedure: Spinal Mobilization With Leg MovementProcedure: Conventional treatment

Group B

ACTIVE COMPARATOR

The patients will be given Spinal mobilization (transverse glide) on the effected spinous process. The total time duration will be 25-30 minutes. Participants will be given Hot pack for 15 minutes, TENS for 10 minutes.

Procedure: Spinal MobilizationProcedure: Conventional treatment

Interventions

Spinal Mobilization With Leg MovementPROCEDURE

spinal mobilization with leg movement is the intervention given to experimental group. This technique involves applying pressure to the relevant spinous process while the patient moves their limb through the previously restricted range of motion. It is assumed that the restriction of movement is due to a spinal issue but it does not always indicate nerve damage as spinal movement is necessary for limb movement beyond a certain point. The goal is to address any spinal mechanical limitations and there may also be potential effects on the nerves.

Group A
Spinal MobilizationPROCEDURE

The patients will be given Spinal mobilization transverse glide(kaltenborn glide) on the effected spinous process. The total time duration will be 25-30 minutes.

Group B
Conventional treatmentPROCEDURE

Participants will be given Hot pack for 15 minutes, TENS for 10 minutes

Group AGroup B

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with lumbar Radiculopathy with unilateral radiating leg pain.
  • Both Genders with Age between 20 to 50 Years.
  • Patient willing to participate and complete their follow-ups.
  • Pain from (0-35 degrees) in Straight Leg Raise(Dural Pain).
  • Positive neurodynamic test i.e. SLR test(35-70 degrees),which indicate sciatica)
  • Pain more 3-5 or More on NPRS.

You may not qualify if:

  • Spinal stenosis.
  • Cauda equina syndrome.
  • Patients having Somatic referred pain.
  • Specific diseases of spine like ankylosing spondylitis, ,vertebral collapse, Rheumatoid arthritis, and Spondylolisthesis.
  • Tb spine, intermittent claudication,diabetic neuropathy.
  • Recent infection.
  • Mental retardation.
  • Previous spinal Surgery.
  • Pelvis Fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NCS University Rehabilitaion Centre Swabi

Swabi, KPK, 23430, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A Single blinded study will be used in which data analyzer will be blind.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prallel Group Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2023

First Posted

July 21, 2023

Study Start

February 15, 2023

Primary Completion

September 20, 2023

Study Completion

February 10, 2024

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

PA(1)