Effects of Dry Needling in Patients With Upper Cross Syndrome

March 4, 2021 updated by: Riphah International University

Effects of Dry Needling on Pain, Range of Motion and Function in Patient With Upper Cross Syndrome

The study will be done to evaluate the effectiveness of dry needling of muscles involved in Upper Cross Syndrome. Muscles involved in upper cross syndrome are tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids. Physical assessment of trigger points will locate the target area for dry needling. After pre treatment measurements, dry needling will be performed to treatment group and stretching, hot pack and tens will be apply in control group. Study design will be randomized controlled trial and sample size will be 34 participants. Data will be collected from Riphah Rehabilitation Center. Patients of 20-50 years old with UCS diagnosed through observation and physical examination will be included. Patients with systemic soft tissue and bony diseases will be excluded. Intervention duration will be two session of DNT with two weeks routine management. Basic tools will be Visual analog scale (VAS), Neck Disability Index (NDI) and Goniometry

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Dry needling is relatively new method for the management of musculoskeletal pain.Different methods of dry needling, its effectiveness, and physiologic and adverse effects are discussed. Dry needling is a treatment modality that is minimally invasive, cheap, easy to learn with appropriate training, and carries a low risk. The deep method of dry needling has been shown to be more effective than the superficial one for the treatment of pain associated with myofascial trigger points. However, over areas with potential risk of significant adverse events, such as lungs and large blood vessels, we suggest using the superficial technique, which has also been shown to be effective. Questionnaire for assessing the improvement in quality of life is by NDI and ranges like neck flexion/extension, side bending and rotation will be measured by standard goniometry. Neck disability index will use to check the patient's ability to perform his ADL before and after the treatment/control. Data will be collected from Riphah rehab center. Assessed patients of UCS of age 20 to 50 will be the targeted population of this study. Patients with systematic and bony disease excluded from the study. Population having stiff upper back, tight trap and stiff upper thoracic spine have UCS. Ethical guidelines will be followed for both treatment and control group. SPSS version 21 will be use for data analysis with sample size of 34 participants, 17 participants each group that will randomly allocated in treatment/control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rahim Yar Khan, Punjab, Pakistan
        • Sheikh Zaid Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stiffness and gradual pain in neck and shoulder
  • Pain due to Postural Dysfunction
  • Trauma or insidious onset

Exclusion Criteria:

  • Any systemic soft tissue and bony disease.
  • Patient with spinal tuberculosis, spinal fractures, pregnancy, cancer.
  • Any recent surgery.
  • Patient with any cervical or thoracic problem.
  • Patients with any other serious pathology/red flags

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Dry Needling
Other: Dry Needling
Dry needling on Upper trapezius, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids for 10 min
Active Comparator: Group B
Hot pack , TENS , Stretching
Other: Hot pack , TENS , Stretching

Treatments are

  1. Hot Pack for 15 minutes
  2. TENS for 10 minutes
  3. Stretching

The third treatment which is Stretching will be given one time on each muscle (tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids) of upper spine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 2nd Week
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured
2nd Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neck Disability Index Questionnaire
Time Frame: 2nd Week
Neck disability index is a self report questionnaire use to determine how neck pain effects the patients daily life and to assess the self rated disability of patients with neck pain. Area of assessment are activities of daily life, attention ,work memory ,functional mobility ,pain ,occupational performance ,quality of life and sleep. Totally based on patient reported outcome
2nd Week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Goniometer
Time Frame: 2nd Week
Goniometer is an instrument particularly useful when measuring the spine where you can use it to measure flexion, extension, side bending and rotation quickly and easily
2nd Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/LHR/20/1049 Komal Arooj

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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