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Segmental Mobilization vs Entire Spine Mobilization In Lumbar Spondylosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158115
Recruitment Status : Completed
First Posted : November 8, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Riphah International University

Brief Summary:

This study will compare the effect of segmental spine mobilization and entire spine mobilization in the patients with lumber spondylosis.

There will be two groups ; experimental and control. Half of study group will receive segmental mobilization along with conventional treatment such as moist heat , soft tissue mobilization and traditional stretching exercises and half of study group will receive entire spine mobilization along with the same conventional treatment given to other group.


Condition or disease Intervention/treatment Phase
Spondylosis Lumbar Other: Entire Spine Mobilization Other: Segmental Mobilization Not Applicable

Detailed Description:

This is a randomized controlled trial which is being conducted in Pakistan Railway hospital enrolled total 40 participants diagnosed with lumbar spondylosis who fulfilled the inclusion criteria through sealed envelope method using purposive sampling technique into two groups I-e experimental (n=21) and control group(n=19).The treatment protocol administered to experimental group was Maitland entire spine mobilization along with other conventional treatments such as hot pack, soft tissue mobilization.

and home-based exercises (Bridging, knee to chest, Hamstrings stretching and TA stretching). While the control group received segmental spine mobilization along with same conventional treatment as mentioned above for 8 sessions. Physical therapy along with pharmaceutical management is effective in improving pain on NPRS, ODI values in patients with lumbar stenosis. Based on evidence that manual therapy interventions when used in combination with exercise therapy in clinical practice has beneficial effect in the treatment of degenerated lumbar spinal stenosis.

effects of 'specific segmental level 'spinal joint mobilization techniques in creating positive outcomes on pain NPRS measures and range of motion concluded that a single session of segmental joint mobilization can lead to pain reduction at both rest and with most painful offending movement.

Manual therapy approaches such as Maitland mobilizations are more productive in the management of chronic low back pain, quality of function and lumbar spine range of motion in patients of lumbar spondylosis than traditional physical therapy interventions such as muscle stretching and spinal traction.

Osteophytes were the most numerous radiographic feature detected in patients with lumbar spondylosis, with greater occurrence in men. Intervertebral disc space narrowing was more prevalent in women than men. Both distinctive radiographic features presence increased with increasing age. Disc space reduction seemed more strongly related with chronic low back pain than osteophytosis, especially in men and disc space narrowing at 2 or more segments appeared more powerfully associated with low back pain than disc space reduction at only 1 intervertebral segment.

Maitland posteroanterior spinal mobilizations are performed by a therapist on symptomatic segments after assessment compared with mobilization treatment given on any random spinal segment in patients suffering with chronic low back pain. The results were greater degree of immediate reduction of pain in patients receiving posteroanterior mobilization on symptomatic segment rather than any random segments in offending movement direction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Between Segmental Mobilization And Entire Spine Mobilization In Lumbar Spondylosis
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : May 30, 2019
Actual Study Completion Date : June 30, 2019

Arm Intervention/treatment
Experimental: Entire Spinal Mobilization
Entire Spinal Mobilization( All spinal segment from Co-C1to L5-S1 Moist heat. Soft tissue Mobilization Exercises. (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)
Other: Entire Spine Mobilization
8 sessions of Following: -Entire Spinal Mobilization of all spinal segment from C0 to C1 to L5 to S1 (10 reps × 3 sets), - Moist heat: 10 to 15 minutes, - Soft tissue Mobilization, - Exercises : (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)

Active Comparator: Segmental Mobilization
Segmental Mobilization. (All lumbar segment from L1-L2 to L5-S1) Moist heat. Soft tissue Mobilization Exercises (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)
Other: Segmental Mobilization

8 sessions of following -Segmental Mobilization: All lumbar segment from L1 to L2 to L5 to S1 (10 reps × 3 sets) - Moist heat: (10 to 15 minutes), -Soft tissue Mobilization

- Exercises: (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)





Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 8th day ]
    Oswestry disability index is basically a tool established by Jeremy Fairbank et al to measure functional outcome and quality of life of persons suffering from low back pain. It consists of total of 10 questions, Every question sores from 0-5 containing 6 questions, which constitutes total of 60 marks for 10 questions. By increasing the value of ODI degree of disability increases. If the percentage fall in 0-20% it indicates minimal disability.21-40% indicates moderately disabled persons, 41 -60% demonstrates severely disabled persons. 61- 80% showed crippled and above 80 are bed bound or psychologically ill patient. Percentages were taken on 1st, 4th and 8th visits to determine the quality of life of patients.

  2. Numeric Pain Rating Scale (NPRS) [ Time Frame: 8th Day ]

    NPRS values was taken as baseline assessment on 1st visit and post intervention assessment after 1st session. Then again, readings were taken on 4th visit. And final reading was taken on 8th visit for both back and legs.

    The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme. Scores range from 0-10 points, with higher scores indicating greater pain intensity.


  3. Spine goniometry [ Time Frame: 8th day ]
    We also measured lumbar flexion, extension, right and left side bending at both baseline and end results after 1st 4th and 8th session of treatment in both the control and experimental groups.



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lumbar spondylosis.
  • Limited ROM (at least two)
  • Symptoms more than month

Exclusion Criteria:

  • Spinal stenosis.
  • Osteoporosis in X-ray.
  • Significant Trauma/Fracture (with in last 06 month)
  • Spondylolysis.
  • Inflammatory arthritis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158115


Locations
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Pakistan
Riphah International university
Rawalpindi, Punjab, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Abdul Ghafoor Sajjad, Phd* Riphah International University
Publications:
Reiman MP, Harris JY, Cleland JA. Manual therapy interventions for patients with lumbar spinal stenosis: a systematic review. InDatabase of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] 2009. Centre for Reviews and Dissemination (UK).
Osama, Muhammad & Malik, Reem & Ahmad, Shakeel. (2017). Effects of facet joint mobilization in patients with straightening of the cervical spine: A pilot study. 10.13140/RG.2.2.15585.10083.

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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04158115    
Other Study ID Numbers: Sadaf nisar REC/00343
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
Lumber Spondylosis
Segmental Mobilization
Spine Mobilization
Additional relevant MeSH terms:
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Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases