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Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain

Primary Purpose

Neck Pain, Mobility Limitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual Therapy
Exercise Program
Sponsored by
Tuğba Akgüller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, mechanical neck pain, manual therapy, exercise

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with MNP
  • Decrease in cervical region ROM
  • Ability to adapt to verbal, written and visual instructions

Exclusion Criteria:

  • Spine surgery history
  • Neurological neck pain in the cervical region
  • Presence of tumor in the cervical region
  • Blood coagulation disorders
  • Vertebrobasilar artery insufficiency
  • Cervical region trauma history
  • Communicative/mental problems that prevent participation in treatment
  • Inflammatory rheumatological diseases affecting the cervical region
  • Physiotherapy and rehabilitation treatments for neck pain in the last 3 months

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Exercise Group

Manual Therapy Group

Manual Therapy and Exercise Group

Arm Description

Exercise Program only

Manual Therapy only

Manual Therapy + exercise program

Outcomes

Primary Outcome Measures

Neck Disability Index
The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).
Pain intensity
Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.

Secondary Outcome Measures

Range of Motion (ROM)
Active neck flexion-extension, right-left lateral flexion and right-left rotation ROM of the participants will be evaluated with cervical goniometer.
Pain Pressure Threshold (PPT)
Participants' PPTs will be evaluated with a pressure algometer (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) that can measure pressure in kilograms and pounds, with a 1 cm diameter circular rubber tip attached to the piston of the pressure gauge
36-Item Short Form Survey (SF-36)
Patients' quality of life will be evaluated with SF-36. This scale is a general health questionnaire that evaluates the person's perception of quality of life in the last four weeks under 8 sub-headings and 36 items. The sub-headings it includes; physical functions, physical roles, pain, social functions, mental health, emotional roles, energy and general health perception.
Patient satisfaction level
Patient Satisfaction will be assessed with the Global Rating of Change (GRC) scale. The scale to be used consists of 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).

Full Information

First Posted
November 13, 2021
Last Updated
May 24, 2023
Sponsor
Tuğba Akgüller
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1. Study Identification

Unique Protocol Identification Number
NCT05154526
Brief Title
Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain
Official Title
Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
April 19, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tuğba Akgüller

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.
Detailed Description
Mechanical neck pain (MNP) is defined as neck pain that becomes evident with the posture of the cervical region, movement or palpation of the cervical region muscles, felt in the cervical, occipital or posterior scapular region without spreading to the upper extremity, and without any trauma or specific pathology underlying the complaints. MNP causes symptoms such as pain in the cervical region, increased sensitivity to pressure, decrease in active range of motion (ROM) of the cervical region, drowsiness, and dizziness. Most of the MNP cases are due to muscular or paraspinal soft tissue problems and show improvement in the first 6 weeks with conservative treatment methods. When the current treatment recommendations are examined according to the duration of neck pain accompanied by limitation of movement, an exercise program that includes thoracic region mobilization, cervical ROM exercises, and strengthening and stretching exercises for the scapulothoracic region and upper extremity muscles is recommended for acute neck pain. In addition, various manual therapy techniques can be applied to the cervical region. In subacute neck pain, an exercise program is applied to increase the endurance of the neck and upper extremity muscles. During this period, various manual therapy methods can be applied to the thoracic and cervical region. In chronic neck pain, combined treatment applications including various exercises, mobilization and manipulation techniques, dry needling, laser and intermittent manual/mechanical traction are recommended. It is stated that the high-velocity low-amplitude technique, which is among the manual therapy techniques and used in many musculoskeletal problems, can increase the ROM, decrease the pain and improve the function. Various manual therapy techniques and various exercises are reported to have positive effects on neck pain. However, the isolated effects of these techniques in people with MNP are not fully known. Therefore, the aim of this study is to determine the effects of two different treatment programs in which the manual therapy technique and the exercise program are applied in individuals with MNP. In addition, comparing the effect of the treatment program in which manual therapy and exercise program are applied together with the isolated effects of these techniques is another aim.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Mobility Limitation
Keywords
neck pain, mechanical neck pain, manual therapy, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
Exercise Program only
Arm Title
Manual Therapy Group
Arm Type
Active Comparator
Arm Description
Manual Therapy only
Arm Title
Manual Therapy and Exercise Group
Arm Type
Active Comparator
Arm Description
Manual Therapy + exercise program
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Manual Therapy: High velocity-low amplitude technique
Intervention Type
Other
Intervention Name(s)
Exercise Program
Intervention Description
Exercise program
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
The neck function of the patients will be evaluated with the Neck Disability Index. The disability levels of the participants due to neck pain will be evaluated with the 'Neck Disability Index' . This scale consists of 10 items including pain intensity, personal care, lifting, reading, headache, concentration, work, driving, sleep status and leisure activities. Each item was scored from 0 (no disability) to 5 (complete disability).
Time Frame
6 weeks
Title
Pain intensity
Description
Pain intensity of the patients at rest, during activity and at night was assessed using the Visual Analog Scale (VAS). In this evaluation, individuals were told that the number "0" on the 10 cm long horizontal line expresses "no pain", and the number "10" indicates "unbearable pain" and that individuals should mark their intensity of pain on this line.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Range of Motion (ROM)
Description
Active neck flexion-extension, right-left lateral flexion and right-left rotation ROM of the participants will be evaluated with cervical goniometer.
Time Frame
6 weeks
Title
Pain Pressure Threshold (PPT)
Description
Participants' PPTs will be evaluated with a pressure algometer (Baseline Push-Pull Force Gauge®, Fabrication Enterprises, Inc.) that can measure pressure in kilograms and pounds, with a 1 cm diameter circular rubber tip attached to the piston of the pressure gauge
Time Frame
6 weeks l
Title
36-Item Short Form Survey (SF-36)
Description
Patients' quality of life will be evaluated with SF-36. This scale is a general health questionnaire that evaluates the person's perception of quality of life in the last four weeks under 8 sub-headings and 36 items. The sub-headings it includes; physical functions, physical roles, pain, social functions, mental health, emotional roles, energy and general health perception.
Time Frame
6 weeks
Title
Patient satisfaction level
Description
Patient Satisfaction will be assessed with the Global Rating of Change (GRC) scale. The scale to be used consists of 5 points (-2: I am much worse. -1: I am worse, 0: I am the same, +1: I am better, +2: I am much better).
Time Frame
At the end of 6-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with MNP Decrease in cervical region ROM Ability to adapt to verbal, written and visual instructions Exclusion Criteria: Spine surgery history Neurological neck pain in the cervical region Presence of tumor in the cervical region Blood coagulation disorders Vertebrobasilar artery insufficiency Cervical region trauma history Communicative/mental problems that prevent participation in treatment Inflammatory rheumatological diseases affecting the cervical region Physiotherapy and rehabilitation treatments for neck pain in the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yıldız Analay Akbaba, PhD
Organizational Affiliation
Istabul University-Cerrahpasa
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Buyukcekmece
ZIP/Postal Code
34500
Country
Turkey

12. IPD Sharing Statement

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Comparison of the Efficiency of Manual Therapy and Exercise in People With Mechanical Neck Pain

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