NCT07080073

Brief Summary

This randomised controlled trial will evaluate the comparative effects of Maitland versus Mulligan spinal mobilization techniques, when combined with canal enlargement exercises, in patients with lumbar spinal stenosis (LSS). A total of 38 participants aged 25-40 years with confirmed unilateral LSS will be randomly assigned to receive either Maitland mobilizations or Mulligan mobilizations, along with standard physiotherapy and canal enlargement exercises. The intervention will be administered over three weeks, with four sessions per week. Primary outcomes will include pain intensity (measured by Numeric Pain Rating Scale), disability (Modified Oswestry Disability Index), and symptom severity (Swiss Spinal Stenosis Score), assessed at baseline and post-treatment. This study aims to inform physiotherapy practice by identifying the more effective manual therapy technique for improving functional outcomes in LSS.

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 1, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 14, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Manual TherapyCanal Enlargement ExercisesPainDisability

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    Pain will be assessed using the 11-point Numeric Pain Rating Scale (NPRS), where 0 represents "no pain" and 10 represents "worst possible pain." The scale is a reliable self-reported tool for evaluating pain intensity in musculoskeletal conditions.

    Baseline and at the end of 3 weeks (post-intervention)

  • Modified Oswestry Disability Index (MODI)

    Functional disability will be assessed using the Modified Oswestry Disability Index (MODI), a validated questionnaire that measures the degree of disability related to low back pain. Scores range from 0% (no disability) to 100% (maximum disability).

    Baseline and at 3 weeks post-intervention

  • Swiss Spinal Stenosis Score (SSSS)

    The Swiss Spinal Stenosis Score (SSSS) will be used to assess symptom severity and physical function specific to lumbar spinal stenosis. The tool includes subscales for symptom intensity and function, with higher scores indicating greater impairment.

    Baseline and at 3 weeks post-intervention

Study Arms (2)

Maitland Mobilization Group

EXPERIMENTAL

Participants in this group will receive Maitland Grade III central posterior-anterior spinal mobilizations targeting the lumbar spine. The intervention will be administered by a licensed physiotherapist with the patient in a prone position, applying oscillatory mobilization for 3 sets of 40 seconds with 1-minute rest intervals. This will be combined with:

Other: Maitland Mobilization Group

Mulligan Mobilization Group

EXPERIMENTAL

Participants in this group will receive Mulligan spinal mobilizations with lower limb movement (SNAGs). The therapist will apply sustained passive glides to the lumbar spinous process while the patient actively elevates the leg in a pain-free range. Mobilizations will be performed in 3 sets of 7-10 repetitions. This will be combined with:

Other: Mulligan Mobilization Group

Interventions

Participants in this group will receive Maitland Grade III central posterior-anterior spinal mobilizations targeting the lumbar spine. The intervention will be administered by a licensed physiotherapist with the patient in a prone position, applying oscillatory mobilization for 3 sets of 40 seconds with 1-minute rest intervals. Canal enlargement exercises (bilateral knee-to-chest, LION stretch, cat-camel exercise) The total treatment will be administered four sessions per week for three weeks (12 sessions total).

Maitland Mobilization Group

Participants in this group will receive Mulligan spinal mobilizations with lower limb movement (SNAGs). The therapist will apply sustained passive glides to the lumbar spinous process while the patient actively elevates the leg in a pain-free range. Mobilizations will be performed in 3 sets of 7-10 repetitions. Canal enlargement exercises (bilateral knee-to-chest, LION stretch, cat-camel exercise) The total treatment will be administered four sessions per week for three weeks (12 sessions total).

Mulligan Mobilization Group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group between 25-40 years
  • Both males and females will be included
  • Patient with low back pain along with unilateral radiating symptoms
  • Having symptoms from at least 3 months with pain severity not more than 7 on NPRS
  • Diagnosed case of slipped disc or herniation causing spinal stenosis, confirmed by physical examination and/or MRI.

You may not qualify if:

  • Chronic inflammatory or infectious disease, neoplasm, hematological disorders, traumatic vertebral injuries, Spondylitis
  • Any concurrent major disease like renal failure, diabetes, cancer, tumor.
  • Low back pain with bilateral radiating symptoms.
  • Pregnancy
  • Cognitive alteration and non-co-operative patient
  • Spinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allama Iqbal memorial teaching hospital

Sialkot, Punjab Province, 1, Pakistan

Location

Related Publications (5)

  • Munakomi S, Foris LA, Varacallo MA. Spinal Stenosis and Neurogenic Claudication. 2023 Aug 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK430872/

    PMID: 28613622BACKGROUND
  • Homayouni K, Naseri M, Zaravar F, Zaravar L, Karimian H. Comparison of the Effect of Aquatic Physical Therapy and Conventional Physical Therapy in Patients with Lumbar Spinal Stenosis (a Randomized Controlled Trial). Journal of Musculoskeletal Research. 2015;18(01)

    BACKGROUND
  • Gaur P, Goyal M, Singh G. Manual therapy and canal enlargement exercises versus conventional physiotherapy in lumbar stenosis - a study protocol. Revista Pesquisa em Fisioterapia. 2021;11

    BACKGROUND
  • Kumar S, A N. Effect of Integrated Exercise Protocol in Lumbar Spinal Stenosis as Compare with Conventional Physiotherapy- A Randomized Control Trial. International Journal of Neurorehabilitation. 2017;04(06).

    BACKGROUND
  • Maitland G. Management of lumbar spine disorder. Maitland's vertebral manipulation 8th ed United Kingdom: Churchill Livingstone. 2013:230-6.

    BACKGROUND

MeSH Terms

Conditions

Spinal StenosisLow Back PainPain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amna Zia, Phd Scholar

    Riphah International University

    PRINCIPAL INVESTIGATOR
  • Areej Ijaz, MSc Student

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samrood Akram, Phd Scholar

CONTACT

Amna Zia, Phd Scholar

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 23, 2025

Study Start

July 1, 2025

Primary Completion

November 15, 2025

Study Completion

November 30, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations