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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03940339
Other study ID # MMDU/IEC/1369
Secondary ID U1111-1232-1359
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date March 19, 2020

Study information

Verified date June 2020
Source Maharishi Markendeswar University (Deemed to be University)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

1. 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

2. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date March 19, 2020
Est. primary completion date March 18, 2020
Accepts healthy volunteers No
Gender All
Age group 35 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Suboccipital myofascial release
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.
Conventional Physiotherapy
The control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique.

Locations

Country Name City State
India Maharishi Markandeshwar Hospital, Mullana Ambala Haryana

Sponsors (1)

Lead Sponsor Collaborator
Asir John Samuel

Country where clinical trial is conducted

India, 

References & Publications (1)

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.

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 weeks
Primary 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. 2 weeks
Secondary 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. 2 weeks