NCT04158115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

November 6, 2019

Last Update Submit

January 8, 2020

Conditions

Keywords

Lumber SpondylosisSegmental MobilizationSpine Mobilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Entire Spinal Mobilization

EXPERIMENTAL

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

Segmental Mobilization

ACTIVE COMPARATOR

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

Interventions

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)

Entire Spinal 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)

Segmental Mobilization

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International university

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (4)

  • 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).

    BACKGROUND
  • 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.

    PMID: 24421608BACKGROUND
  • 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.

    PMID: 29083391BACKGROUND
  • 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.

    BACKGROUND

Study Officials

  • Abdul Ghafoor Sajjad, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2019

First Posted

November 8, 2019

Study Start

March 1, 2019

Primary Completion

May 30, 2019

Study Completion

June 30, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations