Comparison of the Effects of Different Manual Therapy Techniques in Patients With Cervical Spondylosis

NCT ID: NCT04777318

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2023-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Proprioceptive sensitivity decreases in individuals with neck pain compared to those without neck pain. While organizing the treatment program of patients with neck pain, evaluation of cervical proprioception and its addition to the treatment have gained importance.

The aim of the study was to examine the effects of muscle energy technique applied to patients with chronic neck pain on cervical proprioception and motor control and to compare the results of muscle energy technique application with cervical mobilization techniques.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cervical spondylosis (SS) is defined as chronic disc degeneration due to aging caused by degenerative changes in the muscles, tendons, joints or bones of the neck or shoulder.

The etiology of cervical spondylosis includes various factors such as bad posture, anxiety, depression, neck strain, and overload in sports or occupational activities. Proprioception is defined as sensory feedback that contributes to muscle sensation, postural balance and joint stability. It is possible that loss of cervical proprioception and motor control affect segmental stability. This increases the risk of injury following minor trauma. It has been reported that proprioceptive sensitivity is worse in individuals with neck pain compared to those without neck pain, and the degree of the disorder is related to the severity of pain. Some evidence-based studies have shown that manual techniques improve proprioception and motor control.

It has been shown that Muscle Energy Technique (MET), which has gained popularity in recent years, increases cervical joint mobility and reduces pain in patients with chronic neck pain. MET is a form a manual therapy which uses a muscle's own energy in the form of gentle isometric contractions to relax the muscles via autogenic or reciprocal inhibition mechanism. It has been reported that MET stimulates joint proprioceptors, creates a different movement activity in the area of proprioceptive disorder and allows the central nervous system to normalize proprioceptive and motor coordination in this segment. The effect of MET on cervical proprioception in patients with cervical spondylosis has not been investigated yet.

Active participation of the patient in movement is extremely important in proprioceptive feedback, motor control and motor learning. For this reason, it is thought that investigating the effect of MET, which includes active muscle contractions of the patient, on proprioceptive sense and comparing the results with passive applications (manipulation or mobilization) will be useful in determining the optimal treatment method in cervical spondylosis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Spondylosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Individuals between the ages of 40-65 diagnosed with cervical spondylosis will be included in the study. The sample size was determined as 66 subjects, 22 in each group, under the assumption that the one-way ANOVA test would be applied in the comparison between groups and the effect size would be f = 0.40, α = 0.05, β = 0.20.

Considering the possibility of using the nonparametric equivalent instead of the parametric ANOVA test in the analyzes that will start after the data collection phase, this initial sample size was increased by 15% and corrected to 76 people. Considering that there may be people who may leave the study, this sample size was increased by 25% and the final sample size was determined as 96 people.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional physiotherapy

The individuals in the control group was taken in a total of 12 sessions of conventional physiotherapy program for 4 weeks, 3 days a week.

Group Type EXPERIMENTAL

Conventional physiotherapy

Intervention Type OTHER

A total of 12 sessions of conventional physiotherapy program for 4 weeks were applied 3 days a week. The conventional physiotherapy program included 20 min hotpack , 10 min ultrasound, 20 min conventional (Transcutaneous electrical nerve stimulation) TENS application.

Muscle Energy Technique (MET)

In addition to the conventional physiotherapy program of 12 sessions for 4 weeks, 3 days a week, muscle energy technique was applied to the individuals in the second group.

Group Type EXPERIMENTAL

Conventional physiotherapy and Muscle Energy Technique

Intervention Type OTHER

In addition to conventional therapy, the muscle energy technique was applied to the individuals in the second group at the same frequency. Muscle energy technique was applied to the upper trapezius, sternocleidomastoideus , scalene (anterior-medius-posterior) and levator scapula muscles. According to the MET post-isometric relaxation method, each muscle was applied as one set (each set includes three repetitions). The patient was asked to perform a 7-second isometric contraction corresponding to 20% of the maximum isometric contraction force in the area where the restriction was felt. After the application, the patient was asked to breathe and relax, and the neck was brought back to the barrier point and the technique was repeated.

Cervical Mobilization Techniques (CMT)

In the third group, cervical mobilization techniques was applied in addition to the conventional physiotherapy program for a total of 12 sessions for 4 weeks, 3 days a month.

Group Type EXPERIMENTAL

Conventional physiotherapy and Cervical Mobilization Techniques

Intervention Type OTHER

Cervical mobilization techniques were also applied to the individuals in the third group in addition to conventional physiotherapy at the same frequency. In the first few sessions, bridging and manual traction techniques were applied in 3-5 repetitions. In the next sessions, in addition to these techniques, rotation with 3-5 repetitions of manual traction, anteroposterior sliding with traction and cervical lateral shift techniques were applied. Vertebrobasilar InsufficiencyTest was applied to all participants to determine the appropriateness of cervical mobilization. Before mobilization, a deep friction massage was applied on painful spasmic nuchal muscles for 3-4 minutes in order to increase blood circulation and relax tense tissues.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional physiotherapy

A total of 12 sessions of conventional physiotherapy program for 4 weeks were applied 3 days a week. The conventional physiotherapy program included 20 min hotpack , 10 min ultrasound, 20 min conventional (Transcutaneous electrical nerve stimulation) TENS application.

Intervention Type OTHER

Conventional physiotherapy and Muscle Energy Technique

In addition to conventional therapy, the muscle energy technique was applied to the individuals in the second group at the same frequency. Muscle energy technique was applied to the upper trapezius, sternocleidomastoideus , scalene (anterior-medius-posterior) and levator scapula muscles. According to the MET post-isometric relaxation method, each muscle was applied as one set (each set includes three repetitions). The patient was asked to perform a 7-second isometric contraction corresponding to 20% of the maximum isometric contraction force in the area where the restriction was felt. After the application, the patient was asked to breathe and relax, and the neck was brought back to the barrier point and the technique was repeated.

Intervention Type OTHER

Conventional physiotherapy and Cervical Mobilization Techniques

Cervical mobilization techniques were also applied to the individuals in the third group in addition to conventional physiotherapy at the same frequency. In the first few sessions, bridging and manual traction techniques were applied in 3-5 repetitions. In the next sessions, in addition to these techniques, rotation with 3-5 repetitions of manual traction, anteroposterior sliding with traction and cervical lateral shift techniques were applied. Vertebrobasilar InsufficiencyTest was applied to all participants to determine the appropriateness of cervical mobilization. Before mobilization, a deep friction massage was applied on painful spasmic nuchal muscles for 3-4 minutes in order to increase blood circulation and relax tense tissues.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presence of neck pain of Visual Analog Pain Scale (VAS) ≥ 2 in at least one direction lasting more than three months
* Not having received conservative treatment in the last 6 months

Exclusion Criteria

* Pain or numbness that spreads to the arms
* Having a cervical region surgery
* Having musculoskeletal problems such as shoulder impingement or thoracic outlet syndrome
* Having a contraindication to cervical mobilization (VBI, myelopathy, inflammatory arthropathy, malignancy, etc.)
* Using analgesic drugs
* People who cannot adapt to study
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eastern Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Buse Sezerel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

İNCİ YÜKSEL, Prof. Dr.

Role: STUDY_DIRECTOR

Eastern Mediterranean University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Buse Sezerel

Famagusta, , Cyprus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Cyprus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-0041

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.