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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04158115
Other study ID # Sadaf nisar REC/00343
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date June 30, 2019

Study information

Verified date January 2020
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2019
Est. primary completion date May 30, 2019
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
Pakistan Riphah International university Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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.

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).

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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 8th day
Primary 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.
8th Day
Primary 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. 8th day