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Suboccipitalis Myofascial Release in Hamstring Tightness in Patients With Anterolisthesis

Primary Purpose

Anterolisthesis

Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Suboccipital myofascial release
Conventional Physiotherapy
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterolisthesis focused on measuring Hamstring muscles, Pain measurement, Low back pain

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Patients aged between 35-55 years Both male and female Individuals with Hamstring tightness Individual with Anterolisthesis Individual with pain and disability

Exclusion Criteria:

Individuals with neck pain Patients with history of neck trauma Fracture of lower limb Cervical ligament instability Spinal fractures in the past 6 months Open wounds and skin allergies in the back

Sites / Locations

  • Maharishi Markandeshwar Hospital, Mullana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Suboccipital myofascial release

Coventional Physiotherapy

Arm Description

Treatment will be given for 3 minutes, 3 days per week for 4 weeks.

Treatment will be given for 3 days per week for 4 weeks

Outcomes

Primary Outcome Measures

Popliteal Angle Test
Popliteal angle is an assessment of the tone of the hamstring muscles. The thigh is flexed on the abdomen with one hand and then the other hand straightens the leg by pushing on the back of the ankle until there is firm resistance to the movement. Popliteal angle is measured in degrees.
Modified Oswerstry Disability Index
It is an extremely important tool used to measure a patient's permanent functional disability. The total score range from 0-50.

Secondary Outcome Measures

Visual Analogue Scale
It is a quantifying instrument for subjective characteristics or attitudes of pain that cannot be directly measured. The total score range from 0-10.

Full Information

First Posted
May 1, 2019
Last Updated
June 14, 2020
Sponsor
Asir John Samuel
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1. Study Identification

Unique Protocol Identification Number
NCT03940339
Brief Title
Suboccipitalis Myofascial Release in Hamstring Tightness in Patients With Anterolisthesis
Official Title
Effect of Suboccipital Muscle Myofascial Release on Hamstring Muscle Length, Pain and Disability in Patients With Anterolisthesis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to COVID-19 lockdown
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Asir John Samuel

4. Oversight

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

5. Study Description

Brief Summary
Background: Anterolisthesis presents with tightness of hamstring muscle which is a major contributing factor for low back pain and disability. Suboccipital Myofascial release decreases the tension in the fascia and helps to amend the muscle imbalance. There is a presence of superficial backline between suboccipitalis and hamstring muscle. Aim: The purpose of the study is to find out the effect of sub occipital myofascial release on hamstring tightness along with pain and disability associated with it in Anterolisthesis. Methods: The study will recruit individuals with Anterolisthesis between the age of 35- 55. Pathologies which will limit or interfere with the test outcome shall be excluded. The samples will be collected using criterion based sampling. Procedure will be explained prior to the intervention Data analysis: Normality of the collected data will be established by Shapiro Wilk Test. Based on the normality, descriptive statistics data will be expressed as mean ± standard deviation or median and intra quartile range. Within group comparison will be done by paired t test or Wilcoxon signed rank test and between group comparison will be done through independent t test or Mann Whitney U test.
Detailed Description
Introduction: Anterolisthesis refers to an anterior displacement of a vertebra over subjacent vertebra causing low back pain, radiculopathy and hamstring tightness. Hamstring tightness causes improper patterns in the lumbopelvic region. There is a dura matter which connects suboccipitalis and hamstring muscle and reduction in the tone of suboccipitalis will thus cause decrease in tone of hamstring muscle. Myofascial release is a manipulative treatment that attempts to release tension in fascia and has an effect to decrease soreness of muscle. 1.1.Problem statement: Generally in patients with anterolisthesis a single component is considered as a treatment, this study thus aims to be a bridge filling the gap in the scientific cognizance 1.2.Purpose of the study:The target of the study is to see the outcome of sub occipitalis myofascial release on tightness of hamstring muscle, pain and disability. 1.3.Objectives of the study: To evaluate the efficacy of suboccipital myofascial release and conventional physiotherapy treatment in tightness of hamstring muscle, pain and disability Procedure: Total male (n) and female (n) patients between the age of 35 and 55 years with grade 1 and 2 Anterolisthesis will be selected on the basis of inclusion and exclusion criteria. The suitable sample will be randomly allocated into 2 groups - experimental and control group respectively. The popliteal angle test will be carried out to assess hamstring length and modified oswestry disability index will be used to quantify disability for low back pain. Visual analogue scale will be used to measure intensity of pain. All the necessary measures will be taken among the participants of experimental group.The MFR technique will be given in the upper cervical region with the patient in supine position. The MFR will be given for three repetitions per session, three times per week for the period of four weeks. The control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterolisthesis
Keywords
Hamstring muscles, Pain measurement, Low back pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group pretest posttest randomized control design
Masking
Participant
Masking Description
Single blinded participants will be recruited
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suboccipital myofascial release
Arm Type
Experimental
Arm Description
Treatment will be given for 3 minutes, 3 days per week for 4 weeks.
Arm Title
Coventional Physiotherapy
Arm Type
Active Comparator
Arm Description
Treatment will be given for 3 days per week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Suboccipital myofascial release
Intervention Description
The MFR technique will be given in the upper cervical region with the patient in supine position. The MFR will be given for three repetitions per session, three times per week for the period of four weeks.
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
The control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique.
Primary Outcome Measure Information:
Title
Popliteal Angle Test
Description
Popliteal angle is an assessment of the tone of the hamstring muscles. The thigh is flexed on the abdomen with one hand and then the other hand straightens the leg by pushing on the back of the ankle until there is firm resistance to the movement. Popliteal angle is measured in degrees.
Time Frame
2 weeks
Title
Modified Oswerstry Disability Index
Description
It is an extremely important tool used to measure a patient's permanent functional disability. The total score range from 0-50.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
It is a quantifying instrument for subjective characteristics or attitudes of pain that cannot be directly measured. The total score range from 0-10.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients aged between 35-55 years Both male and female Individuals with Hamstring tightness Individual with Anterolisthesis Individual with pain and disability Exclusion Criteria: Individuals with neck pain Patients with history of neck trauma Fracture of lower limb Cervical ligament instability Spinal fractures in the past 6 months Open wounds and skin allergies in the back
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bishaka Pradhan, BPT, (MPT)
Organizational Affiliation
Department of Musculoskeletal Physiotherapy, MMIPR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maharishi Markandeshwar Hospital, Mullana
City
Ambala
State/Province
Haryana
ZIP/Postal Code
133207
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet decided
Citations:
Citation
Vatsal DK, Kainth R, Kainth R, Husain PM. Original Article A clinico-etiological study of spondylolisthesis in north Indian population. Int J Med Sci Clin Invent. 2017;4(5):2884-7.
Results Reference
result

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Suboccipitalis Myofascial Release in Hamstring Tightness in Patients With Anterolisthesis

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