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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hamstring stretching with Pressure Biofeedback Unit
Hamstring stretching with out Pressure Biofeedback Unit
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Hamstring length, Low back Pain, Pressure Biofeedback unit

Eligibility Criteria

25 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Railway General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hamstring stretching with Pressure Biofeedback Unit

Hamstring stretching with out Pressure Biofeedback Unit

Arm Description

Hot pack, Hamstring stretching with Biofeedback unit, TENS

Hot pack, Hamstring stretching without Biofeedback unit, TENS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain through NPRS
Changes from baseline, Pain was measured through Numeric pain rating scale. 0 represents "no pain" and 10 "worst pain possible".
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".

Full Information

First Posted
September 17, 2021
Last Updated
September 17, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05059496
Brief Title
Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.
Official Title
Effects of Hamstring Stretching Using Pressure Biofeedback Unit in Patients With Low Back Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Hamstring length, Low back Pain, Pressure Biofeedback unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hamstring stretching with Pressure Biofeedback Unit
Arm Type
Experimental
Arm Description
Hot pack, Hamstring stretching with Biofeedback unit, TENS
Arm Title
Hamstring stretching with out Pressure Biofeedback Unit
Arm Type
Active Comparator
Arm Description
Hot pack, Hamstring stretching without Biofeedback unit, TENS
Intervention Type
Other
Intervention Name(s)
Hamstring stretching with Pressure Biofeedback Unit
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hamstring stretching with out Pressure Biofeedback Unit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamstring Length
Description
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.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Pain through NPRS
Description
Changes from baseline, Pain was measured through Numeric pain rating scale. 0 represents "no pain" and 10 "worst pain possible".
Time Frame
12 days
Title
Functional Status
Description
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".
Time Frame
12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Momena Shahzad, MS
Phone
+92-334-2848148
Email
momena.shahzad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
Imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momena Shahzad, MS-OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Railway General Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Momena Shahzad, MS-OMPT
Phone
+92-334-2848148
Email
momena.shahzad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Maryum Rahim, MS-OMPT*

12. IPD Sharing Statement

Plan to Share IPD
No

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

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