Effect of Manual Therapy on Non Specific Neck Pain

December 29, 2023 updated by: Ömer Osman Pala, Abant Izzet Baysal University

Effects of Upper Thoracic Mulligan Mobilization for Pain, Range of Motion and Function in Patients With Mechanical Neck Pain

The aim of this study is to investigate the effects of Mulligan concept Reverse Natural Apophysial Glide Technique (RNAGS)technique applied to the thoracic region on pain, limitation of movement, and functionality in individuals with mechanical neck pain.

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

When we look at the studies investigating the effectiveness of different treatment modalities in non-specific neck pain (NSNP), there is no method accepted as the gold standard for the treatment of NSNP. One of the preferred treatment options for NSNP is physiotherapy and rehabilitation. Physiotherapy and rehabilitation includes electrotherapy modalities, therapeutic exercises, joint mobilisation and manipulations, myofascial release. Among these treatments, manual therapy, which targets the harmony of structure and function, is one of the most preferred treatment methods by physiotherapists. Manual therapy provides improvement by orienting the body's biomechanics, circulation and body structure by directly affecting the joints, muscles and soft tissues. In the literature, there are studies on both cervical mobilisation and thoracic mobilisation for neck pain. Cervical mobilisation and manipulation in neck pain are controversial because they carry certain risks. It has been reported that mobilisation of the thoracic spine decreases pain in the cervical region and increases mobilisation in this region. When the literature was examined, there was no study examining the effect of the Mulligan concept natural apophyseal reversal technique applied to the thoracic region on NSNP. This study was planned to investigate the effect of natural apophyseal reversal on pain and mobility limitation in individuals diagnosed with NSNP.

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.
69

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

  • Turkey
      • Bolu, Turkey, 14300
        • Faculty of Health Sciences Bolu Abant Izzet Baysal University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Those between the ages of 18-65
  • Those with neck pain lasting at least 3 months
  • Individuals diagnosed with mechanical neck pain by a specialist physician

Exclusion Criteria:

  • Those with a history of spinal surgery
  • Those with a history of whiplash injury
  • Those with a history of trauma in the cervical and thoracic region
  • Pregnancy

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Mulligan group (MG)
Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional transcutaneous electrical nerve stimulation (TENS) was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.In addition to physiotherapy applications in MG, Mulligan natural apophyseal reversal technique was applied to the upper thoracic segments. Mulligan mobilization was performed with 3 sets of 10 repetitions and 15-20 seconds of rest between sets.
Other: Mulligan Reverse Natural Apophysial Glide Technique (RNAGS)

Mulligan mobilization techniques was applied to the upper thoracic segments with the RNAGS technique. The application was performed with one hand (thumb in extension, other fingers flexed) that was used to perform the pushing maneuver on the transverse processes, while the other arm was used to gently grasp the head of the patient and recline the neck against the body for stabilization.

Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist.

Other Names:
  • TENS
  • Stretching exercises
  • Hotpack
  • Utrasound
Sham Comparator: Sham (different in the direction and amplitude of mobilization) group
Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.Sham mobilization was applied to the segments where Mulligan mobilization was carried out in Sham group, in which the direction of thrust and thrust were different.
Other: Conventional physical therapy and sham manual therapy

A sham Mulligan RNAGS technique with low pressure compression was applied to thoracic region.

Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist.

Other Names:
  • TENS
  • Stretching exercises
  • Hotpack
  • Utrasound
Other: Physiotherapy group
Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.
Other: Conventional physical therapy
Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist
Other Names:
  • TENS
  • Stretching exercises
  • Hotpack
  • Utrasound

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
Joint Range of Motion Assessment (ROM)
Time Frame: 3 weeks
Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
3 weeks
Pain Assessment
Time Frame: 3 weeks
Visual analogue scale (VAS) was used to assess the severity of mechanical neck pain. Individuals were asked to mark the pain they felt on a 10 cm long VAS scale ("0" indicates no pain and "10" indicates unbearable pain).
3 weeks
Neck Disability Status Assessment (NDI)
Time Frame: 3 weeks
Evaluate neck disability status A questionnaire consisting of 10 items. Seven items are related to activities of daily living, two are related to pain intensity and one is related to concentration. The response to each item is scored between 0 (no limitation) and 5 (maximum limitation) and the final NDI score is obtained by summing each score
3 weeks

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.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omer Osman PALA, PhD, Abant Izzet Baysal University

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.
January 1, 2021

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.
May 30, 2021

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.
May 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 29, 2023

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 29, 2023

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.
January 10, 2024

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.
January 10, 2024

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.
December 29, 2023

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.
December 1, 2023

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.
  • AIBU-FTR-ÖOP-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan for data sharing.

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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