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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

Tracking Information
First Submitted Date  ICMJE November 6, 2019
First Posted Date  ICMJE November 8, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2019)
  • 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.
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Segmental Mobilization vs Entire Spine Mobilization In Lumbar Spondylosis
Official Title  ICMJE Comparison Between Segmental Mobilization And Entire Spine Mobilization In Lumbar Spondylosis
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Spondylosis Lumbar
Intervention  ICMJE
  • 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)
  • 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)

Study Arms  ICMJE
  • 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)
    Intervention: Other: Entire Spine Mobilization
  • 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)
    Intervention: Other: Segmental Mobilization
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04158115
Other Study ID Numbers  ICMJE Sadaf nisar REC/00343
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Riphah International University
Study Sponsor  ICMJE Riphah International University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Abdul Ghafoor Sajjad, Phd* Riphah International University
PRS Account Riphah International University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP