NCT03940339

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

7 months

First QC Date

May 1, 2019

Last Update Submit

June 14, 2020

Conditions

Anterolisthesis

Keywords

Hamstring musclesPain measurementLow back pain

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Visual Analogue Scale

    2 weeks

Study Arms (2)

Suboccipital myofascial release

EXPERIMENTAL

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

Other: Suboccipital myofascial release

Coventional Physiotherapy

ACTIVE COMPARATOR

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

Other: Conventional Physiotherapy

Interventions

Suboccipital myofascial releaseOTHER

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.

Suboccipital myofascial release
Conventional PhysiotherapyOTHER

The control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique.

Coventional Physiotherapy

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

Location

Related 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.

    RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bishaka Pradhan, BPT, (MPT)

    Department of Musculoskeletal Physiotherapy, MMIPR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinded participants will be recruited
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two group pretest posttest randomized control design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Supervisor and Associate Professor, Department of Pediatric and Neonatal Physiotherapy

Study Record Dates

First Submitted

May 1, 2019

First Posted

May 7, 2019

Study Start

September 1, 2019

Primary Completion

March 18, 2020

Study Completion

March 19, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

It is not yet decided

Locations

IN(1)