NCT05969912

Brief Summary

To compare the effects of Bowen's and Graston Technique in patients of chronic low back pain for reducing pain, enhancing lumbar range of motion and physical functioning and reducing depression.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 23, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

July 23, 2023

Last Update Submit

August 31, 2023

Conditions

FibromyalgiaLow Back Pain

Keywords

Bowen techniqueInstrument assisted soft tissue mobilization

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia impact questionnaire (FIQ)

    The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes. It has been designed to measure the components of health status that are believed to be most affected by FM.

    3 weeks

Secondary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    3 weeks

  • Clinically useful depression outcome scale (CUDOS)

    3 weeks

  • Bubble inclinometer

    3 weeks

Study Arms (2)

Graston Technique (Instrumented assisted soft tissue mobilization)

ACTIVE COMPARATOR

Graston technique + Conventional PT

Other: Graston Technique (Instrumented assisted soft tissue mobilization)

Bowen's Technique (Soft tissue technique)

ACTIVE COMPARATOR

Bowen's technique + Conventional PT

Other: Bowen's Technique(Soft tissue technique)

Interventions

Graston Technique (Instrumented assisted soft tissue mobilization)OTHER

They would received Graston technique (Instrumented assisted soft tissue mobilization) as follow: Using lubricant (Vaseline) on the skin then a stainless steel instrument to relax the fascia and muscles. Frequency: 60 reps per min for 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Graston technique (Instrument assisted soft tissue mobilization) Additionally, the would receive Conventional PT : Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks

Graston Technique (Instrumented assisted soft tissue mobilization)
Bowen's Technique(Soft tissue technique)OTHER

They would received Bowen's technique (Soft tissue technique) as follow: Bowen moves (15 - 20 times) with 2 mins gap between each set. Frequency: 3 times/week for 3 consecutive weeks Intensity: moderate intensity (pain free) Time: 20 mins Type: Bowen's technique (Soft tissue technique) Additionally, the would receive Conventional PT : Ultrasound for 5 min Stretching exercises at lumbar : Frequency: 10 reps with 5 sec hold for 3 times/week for 3 weeks

Bowen's Technique (Soft tissue technique)

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 30 and 65 years
  • Both Genders
  • Patients with fibromyalgia were included in the study if they fulfilled criteria of the American college of rheumatology for fibromyalgia.
  • Patients having chronic mechanical low back pain of more than three months

You may not qualify if:

  • Patients with tumor, infection and major trauma to the spine causing fracture or disruption of spine.
  • Patients with cauda equina syndrome
  • Any neurological disorder
  • Any previous spinal fusion surgery or spinal cord stimulation.
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daultala centre of CBR/CBID Daultala centre of CBR/CBID and (ALP Hospital Rawalpindi).

Gujar Khān, Pakistan

RECRUITING

MeSH Terms

Conditions

FibromyalgiaLow Back Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • KINZA ANWAR, MS-OMPT

    RIPHAH INTERNATIONAL UNIVERSITY,ISLAMABAD,PAKISTAN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

KINZA ANWAR, MS-OMPT

CONTACT

+92-3239735427kinza.anwar@riphah.edu.pk

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

July 23, 2023

First Posted

August 1, 2023

Study Start

August 30, 2023

Primary Completion

March 30, 2024

Study Completion

April 5, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)