NCT06955117

Brief Summary

A comparative study evaluating the effectiveness of the McKenzie technique versus manual therapy in patients with nonspecific low back pain. The study aims to assess which intervention is more effective in reducing pain and improving functional mobility.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
11mo left

Started Feb 2025

Typical duration for not_applicable low-back-pain

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

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Study Timeline

Key milestones and dates

Study Progress56%
Feb 2025Apr 2027

Study Start

First participant enrolled

February 17, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2027

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

2.2 years

First QC Date

April 24, 2025

Last Update Submit

May 21, 2025

Conditions

Keywords

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • To assess the change in pain intensity

    Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse outcomes. Pain levels will be assessed from baseline to the end of the intervention period.

    6 Months

Secondary Outcomes (1)

  • Disability score

    6months

Other Outcomes (1)

  • lumbar range of motion

    6 months

Study Arms (2)

McKenzie Technique (Group A)

EXPERIMENTAL

Experimental - McKenzie Technique (Group A) Intervention Type: Physical Therapy Intervention Name: McKenzie Extension Exercises Description: This group will receive McKenzie-based physical therapy including postural correction, prone lying, prone on elbows, prone press-ups (3×10), soft tissue mobilization (5-10 mins), lumbar mobilization (PA glide, side-lying rotations), METs (pelvic tilts, hip flexor stretch), core exercises (bridge, dead bug), plus hot pack (15-20 mins) and TENS (10 mins) before and after therapy.

Other: Physical Therapy Exercises

Active Comparator: Manual Therapy (Group B)

ACTIVE COMPARATOR

Physical Therapy Intervention Name: Manual Therapy and Exercises Description: Participants will receive soft tissue mobilization, lumbar mobilization (PA glide, side-lying rotations), METs (pelvic tilts, hip flexor stretch), core exercises (bridge, dead bug), general stretching, hot pack (15-20 mins), and TENS (10 mins) before mobilization. No McKenzie techniques will be applied.

Other: Physical Therapy ExercisesOther: Group B

Interventions

Experimental - McKenzie Technique (Group A) Intervention Type: Other: Physical Therapy Exercises Other Names: Intervention for low back pain Description: Soft Tissue Mobilization: Manual massage to release muscle tension (5-10 mins) Lumbar Mobilization Techniques: PA Mobilization (Posteroanterior glide) on the lumbar spine (Grade I-IV, 3-5 min per segment) Side-lying Rotational Mobilization (3 sets × 10 reps) Muscle Energy Techniques (METs): Pelvic Tilts (3 sets × 10 reps) Hip Flexor Stretch with Isometric Hold (3 sets × 10 sec per side) Core Stabilization Exercises: Bridge Exercise (3 sets × 10-15 reps) Dead Bug Exercise (3 sets × 10 reps per side) Modalities: Hot Pack (15-20 mins) for relaxation before therapy TENS (10 mins) for pain relief before mobilization

Also known as: intervention for low backpain
Active Comparator: Manual Therapy (Group B)McKenzie Technique (Group A)
Group BOTHER

Manual Therapy (Group B) Description: Soft Tissue Mobilization: Manual massage to release muscle tension (5-10 mins) Lumbar Mobilization Techniques: PA Mobilization (Posteroanterior glide) on the lumbar spine (Grade I-IV, 3-5 min per segment) Side-lying Rotational Mobilization (3 sets × 10 reps) Muscle Energy Techniques (METs): Pelvic Tilts (3 sets × 10 reps) Hip Flexor Stretch with Isometric Hold (3 sets × 10 sec per side) Core Stabilization Exercises: Bridge Exercise (3 sets × 10-15 reps) Dead Bug Exercise (3 sets × 10 reps per side) Modalities: Hot Pack (15-20 mins) for relaxation before therapy TENS (10 mins) for pain relief before mobilization

Also known as: Manual Therapy (Group B)
Active Comparator: Manual Therapy (Group B)

Eligibility Criteria

Age35 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of nonspecific low back pain lasting more than 4 weeks
  • Willing to participate and comply with the study protocol

You may not qualify if:

  • History of lumbar spine surgery
  • Presence of spinal fracture, tumor, or infection
  • Pregnant women
  • Severe osteoporosis or spinal deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international University Malakand

Malakand, KPK, 23060, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise TherapyMethodsMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesInvestigative TechniquesComplementary Therapies

Study Officials

  • Dr.Nadeem Ahmad, MS

    Riphah International University Malakand Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Nadeem Ahmad, MS

CONTACT

Dr.Nadeem Ahmad, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: one receiving McKenzie Technique and the other receiving Manual Therapy. Both groups will receive interventions independently to compare outcomes on pain and function in low back pain patients.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 2, 2025

Study Start

February 17, 2025

Primary Completion (Estimated)

April 17, 2027

Study Completion (Estimated)

April 17, 2027

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations