AnterolisthesisNCT03940339
Suboccipitalis Myofascial Release in Hamstring Tightness in Patients With Anterolisthesis
A study testing Suboccipital myofascial release and Conventional Physiotherapy in people with Anterolisthesis, run by Asir John Samuel at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Anterolisthesis
- What is being tested?
- Suboccipital myofascial release and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndia
- Study dates
- 1 Sep 2019to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged between 35-55 years Both male and female Individuals with Hamstring tightness Individual with Anterolisthesis Individual with pain and disability
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Suboccipital Muscle Myofascial Release on Hamstring Muscle Length, Pain and Disability in Patients With Anterolisthesis
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.
Read more
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.
Read the 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.
- Conditions
- Anterolisthesis
- Being tested
- Suboccipital myofascial release, Conventional Physiotherapy
- Keywords
- Hamstring muscles, Pain measurement, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Suboccipital myofascial release | Experimental | Treatment will be given for 3 minutes, 3 days per week for 4 weeks. Receives: Other: Suboccipital myofascial release |
| Coventional Physiotherapy | Active comparator | Treatment will be given for 3 days per week for 4 weeks Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (1)
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Sep 2019
- Primary completion18 Mar 2020
- Study completion19 Mar 2020
Why it stopped: Due to COVID-19 lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnterolisthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group pretest posttest randomized control design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Bishaka Pradhan, BPT, (MPT), Principal investigator, Department of Musculoskeletal Physiotherapy, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940339
- Sponsor's protocol ID
- MMDU/IEC/1369
- Other IDs
- U1111-1232-1359
- Status last verified
- Jun 2020
- First submitted
- 1 May 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet decided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Suboccipital Muscle Myofascial Release on Hamstring Muscle Length, Pain and Disability in Patients With Anterolisthesis
- ClinicalTrials.gov ID
- NCT03940339
- Acronym / sponsor ID
- MMDU/IEC/1369
- Conditions
- Anterolisthesis
- Keywords
- Hamstring muscles, Pain measurement, Low back pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 lockdown
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group pretest posttest randomized control design
| Arm | Type | Receives |
|---|---|---|
| Suboccipital myofascial release | Experimental | Other: Suboccipital myofascial releaseTreatment will be given for 3 minutes, 3 days per week for 4 weeks. |
| Coventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyTreatment will be given for 3 days per week for 4 weeks |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged between 35-55 years Both male and female Individuals with Hamstring tightness Individual with Anterolisthesis Individual with pain and disability
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suboccipital myofascial releaseThe 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. | Other | Suboccipital myofascial release |
| Conventional PhysiotherapyThe control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique. | Other | Coventional Physiotherapy |
Primary outcome
Popliteal Angle Test
Time frame: 2 weeks
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
Time frame: 2 weeks
It is an extremely important tool used to measure a patient's permanent functional disability. The total score range from 0-50.
1 secondary outcome
Visual Analogue Scale
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publicationVatsal 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.
- Individual participant dataSharing planned: No. It is not yet decided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bishaka Pradhan, BPT, (MPT) principal investigator
Department of Musculoskeletal Physiotherapy, MMIPR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboccipital myofascial release and Conventional Physiotherapy in people with Anterolisthesis, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Popliteal Angle Test (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.