- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06200038
Effect of Manual Therapy on Non Specific Neck Pain
Effects of Upper Thoracic Mulligan Mobilization for Pain, Range of Motion and Function in Patients With Mechanical Neck Pain
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bolu, Turkey, 14300
- Faculty of Health Sciences Bolu Abant Izzet Baysal University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
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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:
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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.
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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:
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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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Joint Range of Motion Assessment (ROM)
Time Frame: 3 weeks
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Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
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3 weeks
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Pain Assessment
Time Frame: 3 weeks
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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).
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3 weeks
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Neck Disability Status Assessment (NDI)
Time Frame: 3 weeks
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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
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3 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Omer Osman PALA, PhD, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-ÖOP-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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