NCT06200038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 29, 2023

Last Update Submit

December 29, 2023

Conditions

Keywords

Mechanical Neck PainThoracic MobilizationMulliganRange of Motion

Outcome Measures

Primary Outcomes (3)

  • Joint Range of Motion Assessment (ROM)

    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

    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)

    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

Study Arms (3)

Mulligan group (MG)

EXPERIMENTAL

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)

Sham (different in the direction and amplitude of mobilization) group

SHAM COMPARATOR

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

Physiotherapy group

OTHER

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

Interventions

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.

Also known as: TENS, Hotpack, Utrasound, Stretching exercises
Mulligan group (MG)

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.

Also known as: TENS, Hotpack, Utrasound, Stretching exercises
Sham (different in the direction and amplitude of mobilization) group

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

Also known as: TENS, Hotpack, Utrasound, Stretching exercises
Physiotherapy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences Bolu Abant İzzet Baysal University

Bolu, 14300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Transcutaneous Electric Nerve StimulationMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaExercise TherapyAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Omer Osman PALA, PhD

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know the difference between sham and true mobilisation.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 10, 2024

Study Start

January 1, 2021

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

There is no plan for data sharing.

Locations