NCT06625021

Brief Summary

The aim of this study is to compare the effectiveness of chiropractic and different physiotherapy applications on bilateral hand grip strength, grip sensitivity, two-point separation and joint position sense in individuals with mechanical neck pain (NPMO). It is known that the decrease in grip strength and hand functions, especially with increasing age, causes disability in daily life activities and even death. The planned study aims to improve hand functions in individuals with NPMO. 48 individuals diagnosed with mechanical neck pain were included in the study. The 48 individuals were randomly divided into 4 groups via the Randomizer.org website.

  • The first group is the control group (n=12); transcutaneous electric nerve stimulation, ultrasound and appropriate neck exercises are planned to be applied every day for 4 weeks.
  • The second group is the chiropractic group and will be applied twice a week for 3 weeks by me, a Bahcesehir University Chiropractic Masters graduate (2017), targeting the lower cervicals.
  • Classic hand-wrist exercises such as ROM, stretching and strengthening were applied to the third group in all directions of the wrist.
  • In the fourth group, proprioceptive exercises such as joint approximation, traction and mobilization, similar to the classic hand-wrist exercise group, will be performed every day for 4 weeks. The researcher will compare the effects of chiropractic and other physiotherapy techniques with the control group. Measurements will be repeated 4 weeks after the end of the treatment to measure whether the effects after the treatment continue. As a result of the evaluations recorded in a total of 8 weeks, statistical analyses will be performed first for the changes within the four groups and then for the changes between the groups. The basic questions it aims to answer are as follows:
  • Is there a difference between the control group and chiropractic application, classic hand-wrist exercises and proprioceptive exercises in terms of the effects on grip strength, grip sensitivity, joint position sense and two-point discrimination test in individuals with NPMO?
  • Is there an improvement in the pain levels and functional disabilities of the participants?
  • Are the short-term results of the treatments sufficient?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

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

December 28, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

24 days

First QC Date

October 1, 2024

Last Update Submit

October 2, 2024

Conditions

Keywords

Chiropractic ManipulationGrip StrengthNeck Pain of Mechanical OriginRehabilitation ExerciseProprioception

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale

    Visual Analog Scale (VAS) is used to make some values numerically measurable. In order to measure the pain values of all participants subjectively, it is possible to evaluate their pain on a horizontal plane scale of 0-10 centimeters (cm) or 0-100 millimeters (mm). They were asked to mark the values of the pain they felt, with 0 mm indicating no pain and 10 cm or 100 mm indicating the maximum possible pain. The participants were given definitions of the two extreme parts of the VAS and the patients were asked to indicate where their pain was appropriate by making a mark, drawing a line or verbally and recorded in centimeters. The VAS values of the individuals participating in the study were recorded before the treatment, after the treatment and 4 weeks after the end of the treatment, while resting and during activity.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

  • Neck pain and disability scale

    The validity and reliability of the adaptation of the Neck Pain and Disability Scale (NPDS) to Turkish has been proven. In addition to the evaluation of pain, it examines the effects of pain intensity on social, functional, emotional, daily life activities, recreational and occupational factors. Thus, the 29 effects of neck pain on functionality, quality of life and disability are measured. The NPDS, which consists of 20 items, uses a score between 0 and 5. While the scores of each question can be added up to a value between 0 and 100, the higher the total scores, the more severe the pain and the worse the pain is affected.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

  • Copenhagen neck functional disability scale

    The Copenhagen neck functional disability scale is used to measure neck functionality in the presence of neck pain. It is a scale consisting of 15 items that investigates individuals' self-care, sleep status, disability in daily life and social life impact. It measures pain intensity, independence in daily life or disability, future anxiety of pain, social impact and impact during recreational activities. For the first 5 questions, the Yes answer is (0) points, the Occasional answer = (1) points, the No answer is (2) points. For the other questions, the Yes answer is (2) points, the Occasional answer is (1) points, and the No answer is (0) points. Scoring of the scale; While the total score is calculated between 0 and 30 points, the higher the total score, the higher the minimal disability level, and the lower the total score, the lower the minimal disability.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

  • Grip strength

    A Baseline brand hand dynamometer, which is a frequently used device for measuring hand grip strength, was used. The measurements were made with the participants sitting with their arms next to their bodies, 90° elbow flexion, and the forearm in neutral position, and the wrist in 0 to 30° extension for maximal grip strength. The measurements were made bilaterally, with short rest periods, in three measurements. The arithmetic average of the 3 measurements measured bilaterally was taken for evaluation.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

  • Grip force sensitivity

    In order to evaluate the sensitivity of grip force or in other words, the sensitivity of grip pressure, the Baseline brand Pneumatic Bulb Dynamometer device was used. Pneumatic devices have an air-filled bulb-like shape and provide the measurement of grip force. Individuals grip strengths were measured with the Baseline Pneumatic Bulb Dynamometer device. By targeting half of the maximum grip force, the device indicator was shown to the individuals and they were asked to apply 50% of their maximal grip force, keep it in their memory and repeat it. After a few repetitions, the targeted force was asked to be repeated without showing the device screen and the absolute value of the difference was noted. The evaluation was repeated 3 times and recorded as grip force sensitivity error. A few minutes of rest were given for situations such as fatigue and loss of motivation.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

  • Joint position sense

    In the evaluation of range of motion(ROM) of the wrist, the recorded angles were grouped as actively repeated outside the visual field. All movement axes of the wrist were used for measurement. The target angle for extension and flexion movements of the wrist was defined as 30°, and ulnar and radial deviation angles were defined as 15° and 10°, respectively. ROM was evaluated three times in all movement axes and desired positions of the wrist, and the average of these 3 values was recorded as wrist ROM margin of error.

    The first measurements will be taken before treatment. The second measurements are planned to be taken at the end of treatment, 4 weeks after the start. The third measurements will be taken 8 weeks after the start to evaluate the early effects.

Study Arms (4)

Control group

EXPERIMENTAL

-The first group is the control group (n=12); Transcutaneous electrical nerve stimulation, ultrasound and appropriate neck exercises are planned to be applied every day for 4 weeks.

Procedure: Exercises to be done for neck pain of mechanical origin

Chiropractic Group

ACTIVE COMPARATOR

-The second group is the chiropractic group and will be applied twice a week for 3 weeks by me, a Bahcesehir University Chiropractic Masters graduate (2017), targeting the lower cervicals.

Procedure: Chiropractic manipulationProcedure: Exercises to be done for neck pain of mechanical origin

Classic Hand-Wrist Exercises Group

ACTIVE COMPARATOR

-Classic hand-wrist exercises such as range of motion, stretching and strengthening were applied to the third group in all directions of the wrist.

Procedure: Exercises to be done for neck pain of mechanical originProcedure: Classic Hand-Wrist Exercises

Proprioceptive Exercises Group

ACTIVE COMPARATOR

-In the fourth group, proprioceptive exercises such as joint approximation, traction and mobilization, similar to the classic hand-wrist exercise group, will be performed every day for 4 weeks.

Procedure: Exercises to be done for neck pain of mechanical originProcedure: Proprioceptive exercise group

Interventions

Chiropractic manipulation: Lower cervical chiropractic manipulation is a technique used to increase mobility and relieve pain in the lower vertebrae of the neck. However, such procedures should only be performed by trained chiropractors; if done incorrectly, they can lead to serious problems. The patient should be placed in a comfortable position. The supine or side-lying position is usually preferred. Contact is established with the transverse processes of the lower cervical vertebrae. High-velocity, Low-amplitude thrust is applied within anatomical limits. As a graduate of Bahcesehir University Chiropractic Masters Degree, I applied chiropractic twice a week for 3 weeks.

Chiropractic Group

Conservative treatment, which is frequently used in the treatment of mechanical neck pain, was planned. A warm-up period was defined with stretching exercises in all areas of neck movement. Again, isometric exercise should be 10 seconds in all directions. In addition to neck and shoulder mobility exercises, neck region posture exercises were included. It was planned to do these exercises for 4 weeks, 5 days a week, in all 4 groups.

Chiropractic GroupClassic Hand-Wrist Exercises GroupControl groupProprioceptive Exercises Group

The participants of this group will be subjected to wrist range of motion (ROM), stretching and strengthening exercises. Measurements will be made in all axes of motion of the wrist, which are extension, flexion, ulnar and radial deviation. ROM exercises and stretching exercises were applied passively to all axes of motion within anatomical limits. At the last angles of the movement, the individual was forced and stretched without causing discomfort and waited at the last angles for a short time. Stretching exercises were performed five times for each movement. Strengthening exercises for all axes of movement of the wrist will be performed using dumbbells weighing 1 and 2 kilograms and an exercise band suitable for the persons endurance and strength. In exercises performed with dumbbells, all movements of the wrist will be performed against gravity. All applications were applied to the classical hand-wrist exercise group for at least half an hour every day for 4 weeks.

Classic Hand-Wrist Exercises Group

Similar to the classical wrist exercise group, the participants in this group were applied joint range of motion, stretching and strengthening exercises as well as proprioceptive exercises such as joint approximation, traction and mobilization. In addition to all axes of motion of the wrist, active and passive stretching exercises were applied to the forearm flexor and extensor muscles five times each. The resistance and repetition number were gradually increased according to the wrist strength and endurance of the individuals to at least 10 repetitions. Repetitive contraction and rhythmic stabilization techniques were used from proprioceptive neuromuscular facilitation methods. Joint approximation technique and taping of forearm flexor and extensor muscles were used to increase the level of contraction and stimulation of joint receptors. External stabilization and perturbation exercises were performed with an exercise ball against the wall at different angles of the upper extremity.

Proprioceptive Exercises Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals diagnosed with mechanical neck pain
  • Presence of mechanical neck pain that has been ongoing for at least 14 days
  • Newly starting conservative treatment for mechanical neck pain

You may not qualify if:

  • Individuals wanting to withdraw from the study
  • Not signing the informed consent form
  • Using painkillers for neck pain of mechanical origin pain during the application period
  • Presence of upper extremity trauma that may affect grip strength and proprioceptive sense in the last 3 months
  • Vertebrobasilar artery insufficiency
  • Presence of mental retardation and/or inability to communicate
  • Having undergone surgery in the cervical region
  • Presence of neck pain of neurological origin such as stenosis and herniation of cervical segments
  • Presence of sensory deficit in the hand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University Health Practice and Research Hospital

Kahramanmaraş, 46040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeutics

Study Officials

  • Ersin COZVELIOGLU, Ph.D

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 48 individuals diagnosed with mechanical neck pain were included in the study. The 48 individuals were randomly divided into 4 groups via the Randomizer.org website. * The first group is the control group(n=12); transcutaneous electrical nerve stimulation, ultrasound and appropriate neck exercises are planned to be applied every day for 4 weeks. * The second group is the chiropractic group(n=12) and will be applied twice a week for 3 weeks by me, a Bahcesehir University Chiropractic Masters graduate, targeting the lower cervicals. * Classic hand-wrist exercises group(n=12) such as range of motion, stretching and strengthening were applied to the third group in all directions of the wrist. * In the fourth group, proprioceptive exercises group(n=12) such as joint approximation, traction and mobilization, similar to the classic hand-wrist exercise group, will be performed every day for 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 3, 2024

Study Start

December 28, 2022

Primary Completion

January 21, 2023

Study Completion

July 15, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations