NCT04867356

Brief Summary

The main objective of the study is to determine effects of latissimus dorsi stretching on functional disability related to chronic low back pain

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

April 27, 2021

Last Update Submit

July 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oswestry disability index

    The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test has been around since 1980 and is considered the 'gold standard' of low back pain functional outcome tools. SCORE DISABILITY LEVEL 0 - 4 No disability 5 - 14 Mild disability 15 - 24 Moderate disability 25 - 34 Severe disability 35 - 50 Completely disabled The Oswestry Disability Index (aka the Oswestry Low Back Pain Disability Questionnaire) is an ex- tremely important tool that researchers and disability evaluators use

    2 weeks

Study Arms (2)

Spinal Stabilization Exercises (SSE)

ACTIVE COMPARATOR
Other: Spinal Stabilization Exercises (SSE)

Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)

EXPERIMENTAL
Other: Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)

Interventions

Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients. Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc.

Spinal Stabilization Exercises (SSE)

In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.

Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male and female
  • to 60 years
  • chronic mechanical low back pain

You may not qualify if:

  • patients who had any type of injury or fracture which limits rehabilitation
  • patients with the symptoms of radiating pain
  • who had disc pathology and spinal cord injury
  • patients with medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NOSIS clinics Mansehra Pakistan

Mānsehra, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

April 27, 2021

First Posted

April 30, 2021

Study Start

January 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 1, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations