NCT03631082

Brief Summary

This study will be conducted to determine the effects of slump stretching vs lumbar mobilization with exercises in relieving non-radiculating low back pain. There will be two groups; Group I will receive Slump stretching along with standardized exercises and Group II will receive Lumbar mobilizations along with standardized exercises.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable low-back-pain

Status
unknown

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

August 1, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

August 12, 2018

Last Update Submit

August 12, 2018

Conditions

Keywords

effectsslump stretchinglumbar mobilizationnon radiculatingLow back painexercisesquality of lifemodified oswestry low back pain disabilitynumeric pain rating scalefear avoidance beliefs

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rating scale

    On a scale of 0 to 10, with 0 being no pain at all and 10 being the worst pain imaginable.

    2 weeks

  • Modified Oswestry Low Back Pain Disability Questionnaire

    The questionnaire has been designed to give the therapist information as to how the back pain has affected the ability to manage in everyday life.

    2 weeks

  • Short-Form Health Survey (SF-36)

    SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.

    2 weeks

Secondary Outcomes (2)

  • Fear-Avoidance Beliefs Questionnaire

    2 weeks

  • Active range of motion of lumbar spine.

    2 weeks

Study Arms (2)

Slump stretching group

EXPERIMENTAL

Slump stretching will be performed with the patient in the long sitting position. The position will be held for 30 seconds. A total of 5 repetitions will be completed. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, and quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.

Other: Slump stretching

Lumbar mobilization group

ACTIVE COMPARATOR

Maitland Grade 1 - 2 Posterior to anterior lumbar spine mobilization will be applied for 30 - 45 seconds for all segments through L1 to L5 at rate of 1 oscillation per 2 seconds. Patients will also complete a standardized exercise program consisting of pelvic tilts, bridging, wall squats, quadruped alternate arms/legs activities as described by Cleland et al. Patients will perform 10 repetitions of each exercise.

Other: Lumbar mobilization

Interventions

Slump stretching will be provided to this group along with standardized exercises.

Slump stretching group

Lumbar mobilizations will be provided to this group along with standardized exercises.

Lumbar mobilization group

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Individuals with Non-Radiculating Low back pain
  • Test:
  • i. Slump test=positive ii. Straight leg raise=negative

You may not qualify if:

  • Individuals with Radiculating Low Back pain,History of spinal surgery, Disc herniation,Pregnant women, Major diseases (e.g. stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The two groups will be Slump stretching group and Lumbar mobilization group. All physical therapy techniques in both groups will be applied 3 times in a week up to 2 weeks with each session consisting of 25-40 minutes. Group 1 will receive slump stretching along with standardized exercises while group 2 will recieve lumbar mobilization along with standardized exercises. Demographic details of the patients will be collected at baseline (1st Visit) while Modified Oswestry Low Back Pain Disability Questionnaire,Numeric pain rating scale,Fear-Avoidance Beliefs Questionnaire,Active range of motion (AROM) of lumbar spine and Short-Form Health Survey (SF-36) will be measured at baseline, 1st week, and final week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

August 1, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

August 15, 2018

Record last verified: 2018-08