search
Back to results

Segmental Mobilization vs Entire Spine Mobilization In Lumbar Spondylosis

Primary Purpose

Spondylosis Lumbar

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Entire Spine Mobilization
Segmental Mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spondylosis Lumbar focused on measuring Lumber Spondylosis, Segmental Mobilization, Spine Mobilization

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Riphah International university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Entire Spinal Mobilization

Segmental Mobilization

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)
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)
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
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2019
Last Updated
January 8, 2020
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT04158115
Brief Title
Segmental Mobilization vs Entire Spine Mobilization In Lumbar Spondylosis
Official Title
Comparison Between Segmental Mobilization And Entire Spine Mobilization In Lumbar Spondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylosis Lumbar
Keywords
Lumber Spondylosis, Segmental Mobilization, Spine Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entire Spinal Mobilization
Arm Type
Experimental
Arm Description
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)
Arm Title
Segmental Mobilization
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Entire Spine Mobilization
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Segmental Mobilization
Intervention Description
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 Measure Information:
Title
Oswestry Disability Index (ODI)
Description
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.
Time Frame
8th day
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
8th Day
Title
Spine goniometry
Description
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.
Time Frame
8th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdul Ghafoor Sajjad, Phd*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International university
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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).
Results Reference
background
PubMed Identifier
24421608
Citation
Slaven EJ, Goode AP, Coronado RA, Poole C, Hegedus EJ. The relative effectiveness of segment specific level and non-specific level spinal joint mobilization on pain and range of motion: results of a systematic review and meta-analysis. J Man Manip Ther. 2013 Feb;21(1):7-17. doi: 10.1179/2042618612Y.0000000016.
Results Reference
background
PubMed Identifier
29083391
Citation
Sharma A, Alahmari K, Ahmed I. Efficacy of Manual Therapy versus Conventional Physical Therapy in Chronic Low Back Pain Due to Lumbar Spondylosis. A Pilot Study. Med Sci (Basel). 2015 Jun 26;3(3):55-63. doi: 10.3390/medsci3030055.
Results Reference
background
Citation
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.
Results Reference
background

Learn more about this trial

Segmental Mobilization vs Entire Spine Mobilization In Lumbar Spondylosis

We'll reach out to this number within 24 hrs