NCT05059496

Brief Summary

To determine the effects of Hamstring stretching using a pressure Biofeedback unit on muscle length, pain, and functional status in patients with low back pain.

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
38

participants targeted

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

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable low-back-pain

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

Study Start

First participant enrolled

October 13, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

12 months

First QC Date

September 17, 2021

Last Update Submit

September 17, 2021

Conditions

Keywords

Hamstring lengthLow back PainPressure Biofeedback unit

Outcome Measures

Primary Outcomes (1)

  • Hamstring Length

    Changes from baseline, Hamstring length was measured through Goniometer. Normal value of Active knee extension is 90 degree with 90 degree hip flexion. Values less than 70 degree knee extension represents hamstring tightness.

    12 days

Secondary Outcomes (2)

  • Pain through NPRS

    12 days

  • Functional Status

    12 days

Study Arms (2)

Hamstring stretching with Pressure Biofeedback Unit

EXPERIMENTAL

Hot pack, Hamstring stretching with Biofeedback unit, TENS

Other: Hamstring stretching with Pressure Biofeedback Unit

Hamstring stretching with out Pressure Biofeedback Unit

ACTIVE COMPARATOR

Hot pack, Hamstring stretching without Biofeedback unit, TENS

Other: Hamstring stretching with out Pressure Biofeedback Unit

Interventions

Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching with Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.

Hamstring stretching with Pressure Biofeedback Unit

Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching without Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.

Hamstring stretching with out Pressure Biofeedback Unit

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-specific low back pain
  • Chronic pain \> 3 months
  • Participants having (ODI) score minimum 20% to 40%
  • Participants with hamstrings shorter than 70 degrees bilaterally
  • Participants who scored 3 or more than 3 on the Numeric Pain Rating Scale (NPRS)

You may not qualify if:

  • History of fracture and surgery
  • Patients with osteoarthritis and spondylolisthesis
  • Patients with systemic disease except for diabetes mellitus and hypertension
  • Patients with disc herniation and leg length discrepancy
  • Pregnant females
  • Participants with severe back pain or excessive lumber lordosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway General Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Momena Shahzad, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

September 17, 2021

First Posted

September 28, 2021

Study Start

October 13, 2020

Primary Completion

September 30, 2021

Study Completion

February 28, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations