- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07080073
- Original Trial
Effects of Maitland and Mulligan Spinal Mobilizations Along With Canal Enlargement Exercises in Lumbar Spinal Stenosis
Comparative Effects of Maitland and Mulligan Spinal Mobilizations Along With Canal Enlargement Exercises in Patients of Lumbar Spinal Stenosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This single-blinded, randomised controlled trial is designed to compare the effects of two manual therapy techniques, Maitland central posterior-anterior Grade III mobilizations and Mulligan spinal mobilizations (SNAGs), when combined with canal enlargement exercises and conventional physiotherapy. Thirty-eight participants with confirmed unilateral lumbar spinal stenosis will be recruited from the outpatient physiotherapy department at Allama Iqbal Memorial Teaching Hospital, Sialkot.
Participants will be randomly assigned to one of two intervention groups using sealed opaque envelopes. Group A will receive Maitland mobilizations in addition to canal enlargement exercises and conventional physiotherapy, while Group B will receive Mulligan mobilizations along with the same exercise and conventional therapy protocol. The intervention will be administered four times per week over a period of three weeks (total of 12 sessions).
The canal enlargement protocol includes bilateral knee-to-chest exercises, LION stretches, and cat-camel movements, all of which aim to increase lumbar flexion and spinal canal space. Conventional physiotherapy treatment will include the application of hot packs, transcutaneous electrical nerve stimulation (TENS), and stretching of the hamstrings and piriformis muscles.
Primary outcomes will be assessed at baseline and after the 3-week intervention. These include:
Pain intensity (Numeric Pain Rating Scale, NPRS)
Functional disability (Modified Oswestry Disability Index, MODI)
Symptom severity (Swiss Spinal Stenosis Score, SSSS)
Data will be analysed using appropriate parametric and non-parametric statistical tests, based on data distribution. The findings of this study will provide insight into which mobilization technique is more effective in reducing pain and disability and improving function in patients with lumbar spinal stenosis. This may contribute to the development of more evidence-based physiotherapy protocols for LSS management.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samrood Akram, Phd Scholar
- Phone Number: 03324806143
- Email: samood.akram@riphah.edu.pk
Study Contact Backup
- Name: Amna Zia, Phd Scholar
- Phone Number: 03244686993
- Email: amna_zia_17@live.com
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan, 1
- Allama Iqbal memorial teaching hospital
-
Contact:
- Dr Zunaira
- Phone Number: 03316630234
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Maitland Mobilization Group
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:
|
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). |
|
Experimental: Mulligan 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.
This will be combined with:
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: Baseline and at the end of 3 weeks (post-intervention)
|
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)
Time Frame: Baseline and at 3 weeks post-intervention
|
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)
Time Frame: Baseline and at 3 weeks post-intervention
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amna Zia, Phd Scholar, Riphah International University
- Principal Investigator: Areej Ijaz, MSc Student, Riphah International University
Publications and helpful links
General Publications
- 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/
- 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)
- 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
- 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).
- Maitland G. Management of lumbar spine disorder. Maitland's vertebral manipulation 8th ed United Kingdom: Churchill Livingstone. 2013:230-6.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0166 Areej
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
-
University of Kansas Medical CenterCompletedLower Back Pain | Low Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, Postural | Postural Low Back Pain | Mechanical Low Back Pain | Low Back Ache | Recurrent Low Back Pain | Lower Back Pain Chronic | Low Back Pain, Posterior Compartment | Low BackacheUnited States
-
Istanbul UniversityIstinye UniversityCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, Recurrent | Low Back Pain, PosturalTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
General Incorporated Foundation Ryukyuseimeisaiseikai...CompletedChronic Low Back Pain | Non-specific Low Back Pain | Low Back Pain (LBP)Japan
-
University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
-
University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
-
Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
-
Ache Laboratorios Farmaceuticos S.A.Unknown
Clinical Trials on Maitland Mobilization Group
-
Cairo UniversityCompleted
-
Foundation University IslamabadRecruitingSacral TorsionPakistan
-
Imam Abdulrahman Bin Faisal UniversityUnknownNonspecific Neck PainSaudi Arabia
-
Riphah International UniversityCompletedAdhesive Capsulitis of ShoulderPakistan
-
Cairo UniversityEnrolling by invitationCervicogenic Headache | Neck Pain MusculoskeletalEgypt
-
Foundation University IslamabadRecruitingTemporomandibular Joint DysfunctionPakistan
-
Palestine Polytechnic UniversityCompletedTemporomandibular Disorders (TMD)Palestinian Territory, occupied
-
Mücahit ÖZTOPPamukkale UniversityCompleted
-
Universidad Rey Juan CarlosCompletedOsteoarthritis, Knee | Musculoskeletal ManipulationsSpain
-
Cairo UniversityNot yet recruitingChronic Non-specific Neck Pain