NCT06399549

Brief Summary

Low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. However, diagnosis and, in particular, the provision of specialized back pain therapy remain difficult.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

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

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

May 3, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

April 25, 2024

Last Update Submit

April 30, 2024

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • VA

    Visual Analogue Scale (VAS) is one of the pain rating scales 10 for worse and 0 for no pain

    6 Months

Secondary Outcomes (1)

  • SF36

    6 Months

Study Arms (2)

Dead bug exercise

EXPERIMENTAL
Diagnostic Test: Dead bug exercise

The McGill Curl Up

EXPERIMENTAL
Diagnostic Test: The McGill Curl Up

Interventions

Dead bug exerciseDIAGNOSTIC_TEST

the participant in supine, lying on a mat with shoulders, hip joints and knees flexed to 90°. With the lumbopelvic region being maintained in the neutral position, the participant will be instructed to draw in the abdomen, lower two contra lateral limbs (opposite arm and leg) toward the floor, hold for the stipulated time, then return to starting position. The same movement will be repeated with the opposite limbs. In the DBG, both pairs of limbs will be moved an equal number of times withinthe stipulated time. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises.

Dead bug exercise
The McGill Curl UpDIAGNOSTIC_TEST

Lie down on your back. Extend one leg and bend the knee of the other leg. The Side Bridge. Lie on your side, with your forearm on the floor and elbow underneath your shoulder. The Bird Dog. Assume a hands-and-knees position on the floor. The patients in both groups will perform the corresponding exercises 3 days a week for a period of 3 weeks and a rest interval of 2 minutes between exercises along with conventional physiotherapy exercises. The exercise program includes a warm-up session of five exercises (awareness of the back, pelvic tilt, lumbar rotation, arm movements, whole-body movement in standing), well-known exercises targeting the muscles of the back extensors, abdominals, lateral buttocks, trunk rotators, posterior buttocks, leg muscles, oblique abdominals (e.g. the plank, diagonal arm and leg lift), as well as exercises for flexibility. The exercises will be taught to the patients at the end of the first session in both groups.

The McGill Curl Up

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 30-50 years
  • Patient with the history of 3 months nonspecific low back pain
  • Pain intensity (3-7) according to VAS score

You may not qualify if:

  • Spinal stenosis
  • Neurological dysfunction
  • Systemic disease
  • Pregnancy
  • Infections
  • Carcinoma
  • Any fracture or deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Ganga Ram Hospital Physiotherapy department , Mozang

Lahore, Punjab Province, 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
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 3, 2024

Study Start

March 9, 2024

Primary Completion

April 16, 2024

Study Completion

July 30, 2024

Last Updated

May 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)