- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07364721
Maitland Mobilization vs. McKenzie Press-Up in Chronic LBP (LBP)
Comparative Efficacy of Maitland Mobilization vs. McKenzie Press-Up in Chronic Low Back Pain: A Randomized Trial
Study Overview
Status
Conditions
Detailed Description
This randomized controlled trial evaluated physiotherapy interventions in adults with chronic non-specific low back pain (CNLBP). The study was conducted at Salhab Center for Physiotherapy and Al Shifa's Specialized Complex in Bethlehem City between December 2023 and May 2024. These centers were selected for their accessibility and coordinated referral system.
Participants were referred from orthopedic assessment to physiotherapy, where baseline evaluations were completed prior to randomization. Random allocation to intervention groups was performed using a concealed allocation method.
Physiotherapy interventions were delivered by licensed physiotherapists according to standardized treatment protocols to ensure consistency. Treatment sessions consisted of structured therapeutic exercises and manual therapy techniques, with progression individualized based on patient response. Outcome data were collected at baseline and at the end of the intervention period using validated assessment tools. Participant adherence and adverse events were monitored throughout the study. All procedures were conducted in accordance with ethical standards, and informed consent was obtained from all participants.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Bank
-
Bethlehem, West Bank, Palestinian Territories, P150
- Palestine Ahliya University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 and 50 years of age,
- Male or female, with NSLBP localized between the lower rib and the gluteal fold
- Persisting for more than three months and occurring on at least half of the days in the past three months, with pain affecting daily functional activities.
- VAS score between 40 mm and 80 mm at the initial assessment
- No use of NSAID medications during treatment sessions.
Exclusion Criteria:
- Patients younger than 18 or older than 50 years,
- Those with mental health disorders, systemic or neurological diseases, or specific spinal pathologies such as facet joint dysfunction, piriformis syndrome, disc herniation, spinal tumors, spondylitis, spondylolisthesis, spinal stenosis, or spinal osteoporosis. Patients were also excluded if they had contraindications to mobilization, a history of spinal surgery or epidural injections, physiotherapy for LBP within the last six months, a VAS score outside the 40-80 mm range, pregnancy, or a current upper limb injury.
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: Arm 1- Group A :Central PA Maitland mobilization with MFR
Central PA Maitland mobilization with MFR
|
Patient position: The patient assumes a prone position. Therapist position: The therapist stands beside the patient and provides verbal instruction. Direction: Patients were being instructed to perform PPU exercise by using their upper limbs to push their upper body up into spinal extension while the pelvis remained on the treatment table. The patient is trained to extend the lumbar spine to the maximum pain-free range. Frequency: Ten repetitions for three sets with a 30-second break between each set for almost 10 minutes Patient position: The patient assumes a prone position. investigator position: The investigator stands beside the patient and provides verbal instruction. Direction: Patients were being instructed to perform PPU exercise by using their upper limbs to push their upper body up into spinal extension while the pelvis remained on the treatment table. The patient is trained to extend the lumbar spine to the maximum pain-free range. Frequency: Ten repetitions for three sets with a 30-second break between each set for almost 10 minutes |
|
Experimental: Arm 2- Group B:McKenzie PPU exercise with MFR
Patient position: The patient assumes a prone position. investigator position: The investigator stands beside the patient and provides verbal instruction. Direction: Patients were being instructed to perform PPU exercise by using their upper limbs to push their upper body up into spinal extension while the pelvis remained on the treatment table. The patient is trained to extend the lumbar spine to the maximum pain-free range. Frequency: Ten repetitions for three sets with a 30-second break between each set for almost 10 minutes [27]. |
Patient position: The patient assumes a prone position. Therapist position: The therapist stands beside the patient and provides verbal instruction. Direction: Patients were being instructed to perform PPU exercise by using their upper limbs to push their upper body up into spinal extension while the pelvis remained on the treatment table. The patient is trained to extend the lumbar spine to the maximum pain-free range. Frequency: Ten repetitions for three sets with a 30-second break between each set for almost 10 minutes According to Maitland's concept, mobilization technique including passive accessory intervertebral movement was applied to cause movement in the stiff vertebral segment without the active involvement of the muscles [44]. Central PA mobilization technique is a cornerstone of Maitland vertebral mobilization [38]. It can be achieved by passive force onto a vertebral segment in the PA direction [44]. Patient position: When applying this technique, the patient assumes a relaxed and comfortable prone position, with the arms positioned alongside the body [23, 24]. investigator position: The investigator stands close to the patient, with their sternum perpendicular to the selected lumbar spinous process [23]. The investigator uses the ulnar surface of the hand (pisiform) over the selected spinous process in the lumbar spine, another hand taken was placed above the first hand to reinforce, and the elbow should slightly bent with forearm in neutral between supination & pronation. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oswestry Disability Index
Time Frame: 4 WEEKS
|
0% (no disability) to 100% (severe disability)
|
4 WEEKS
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogu Scale
Time Frame: 4 WEEKS
|
0 no pain , 10 severe pain
|
4 WEEKS
|
|
Fear-Avoidance Belief Questionnaire
Time Frame: 4 WEEKS
|
The Fear Avoidance Beliefs Questionnaire (FABQ) scoring involves summing responses to 16 items on a 0-6 Likert scale (0=completely disagree, 6=completely agree
|
4 WEEKS
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Palestine Ahliya U
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
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