Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Hamstring stretching with Pressure Biofeedback Unit; Other: Hamstring stretching with out Pressure Biofeedback Unit

Detailed Description

Several studies have been conducted regarding hamstring stretching with the pelvis anteriorly tilted for treating low back pain but there is very little evidence regarding the use of a pressure biofeedback unit for maintaining anterior pelvic tilt so this study aims to find out whether the hamstring stretching while maintaining anterior pelvic tilt using pressure biofeedback is more effective than hamstring stretching without using pressure biofeedback in patients with low back pain.

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Momena Shahzad, MS; Phone Number: +92-334-2848148; Email: momena.shahzad@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Railway General Hospital
      • Contact: Momena Shahzad, MS-OMPT; Phone Number: +92-334-2848148; Email: momena.shahzad@riphah.edu.pk
      • Principal Investigator: Maryum Rahim, MS-OMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hamstring stretching with Pressure Biofeedback Unit; Hot pack, Hamstring stretching with Biofeedback unit, TENS	Other: Hamstring stretching with Pressure Biofeedback Unit; 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.
Active Comparator: Hamstring stretching with out Pressure Biofeedback Unit; Hot pack, Hamstring stretching without Biofeedback unit, TENS	Other: Hamstring stretching with out 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain through NPRS	Changes from baseline, Pain was measured through Numeric pain rating scale. 0 represents "no pain" and 10 "worst pain possible".	12 days
Functional Status	Changes from baseline, Functional status was measured through Oswestry Disability Index. 0-20 shows "minimal disability", 21-40 "moderate disability", 41-60 "severe disability", 61-80 "crippled" and 81-100 "bed bound patients".	12 days

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Momena Shahzad, MS-OMPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Low back Pain; Hamstring length; Pressure Biofeedback unit
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: REC/00854 Maryum Rahim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No