NCT05708781

Brief Summary

The study aimed to investigate the efficacy of core strengthening and intensive dynamic back exercises on pain, muscle strength, endurance, and functional disability in patients with chronic non-specific low back pain.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
45

participants targeted

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

Timeline
Completed

Started Dec 2022

Geographic Reach
2 countries

2 active sites

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

December 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

November 22, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 20, 2023

Last Update Submit

November 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain

    6 Weeks

  • functional Limitation

    Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.

    6 Weeks

  • Muscle Endurance

    Muscle endurance was assessed by using timed endurance tests including the extensor endurance test, flexor endurance test and the side bridge test. The hold time was recorded in seconds once the patient was not able to maintain the respective endurance test position.

    6 Weeks

Study Arms (3)

CSE Group

EXPERIMENTAL

in addition to Conventional treatment, core strengthening exercise were given

Other: Core strengthening exerciseOther: Control group

IDBE Group

EXPERIMENTAL

in addition to Conventional treatment, intensive dynamic back exercise were given

Other: intensive dynamic back exerciseOther: Control group

Control Group

ACTIVE COMPARATOR

Conventional Treatment

Other: Control group

Interventions

1. Isolated lumbar stabilization muscle training: 2. Bridge track: 3. Dead bug track: 4. Quadruped Track: 5. Supine Track: 6. Side-support Track: 7. Prone Track: 8. Standing Track:

CSE Group

1. Trunk lifting Prone on a couch, hips at the edge, upper part of the body free but supported by the hands against the floor. Strap fixation over the calves. With hands on the forehead, the trunk is lifted to the greatest possible extension in hips and spine. If necessary, starting with support from physical therapist. During pauses a chair in front of the couch supports the patient. 2. Leg lifting Standing by the end of the couch, leaning over to a prone position with the hips against the edge in 90 degree flexion, knees 45 degree and feet on the floor. Strap fixation over the chest. Straps around knees to keep legs together. Both legs are straightened and lifted to the greatest possible extension in hips and spine. Again support from physical therapist is necessary. 3. Pull to neck Sitting on a tool with the arms straight and abducted over the head and hands grasping a weight lever. Against sub-maximal resistance the lever is pulled behind neck and shoulders.

IDBE Group

Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10- second relaxation) were given, and isometric exercise of the back((10 repetitions of two sets with 10 seconds hold) alternate days for six weeks.

CSE GroupControl GroupIDBE Group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-50 years
  • chronic low back pain (\>3 months),

You may not qualify if:

  • Participants with low back pain related to cancer,
  • infection,
  • inflammatory arthropathy,
  • high-velocity trauma,
  • fracture
  • low back pain associated with severe or progressive neurological deficits trauma
  • pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Integral University Hospital

Lucknow, Uttar Pardesh, India

Location

Hashim Ahmed

Najrān, Najran Region, 1988, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hashim Ahmed, PhD

    Najran University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 1, 2023

Study Start

December 20, 2022

Primary Completion

August 17, 2023

Study Completion

September 28, 2023

Last Updated

November 22, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations