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

NCT04777318 | Completed

• 1 other identifier: 2020-0041
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Spondylosis

Keywords

Cervical Spondylosis; Proprioception; Manual Therapies

Outcome Measures

Primary Outcomes (4)

• Neutral head position test (NBPT)

  NBPT as assessed using the CROM (cervical range of motion) device, which is a special goniometer for the neck. NBPT was started when the cervical region is in a neutral position, the individual was asked to turn his head completely to the left or right and return to the neutral position in a controlled manner. The angular difference was recorded in degrees.

  4 week

• Target head position test (HBPT)

  CROM device was used for HBPT evaluation. The researcher passively moved the person's head to the pre-determined target position, 50% of the maximum range of motion. The head was held in the target position for 3 seconds (sec), then the person was asked to move the head to the neutral position first and then actively move it back to the target position. The angular difference was recorded in degrees.

  4 week

• Cervical region movement sensation

  The laser pointer was fixed on the individual's head. The person sat on a chair 1 m away from the ZZ pattern, which was transferred to a 13 cm high A4 paper with 23.4 horizontal and 26.6 long diagonal stripes fixed to the wall. The pattern has five thin additional lines every 5 mm from the baseline to differentiate the five deviation zones. The test was recorded with a camera 50 cm from the center of the pattern. Individuals will be asked to follow the bands of the pattern as accurately and as quickly as possible, starting from the center of the pattern, and the test was considered complete when it returns to its starting position. After the test, video files were examined at 1/8 of the normal speed, to be used in analysis; time, error frequency and error size were calculated.

  4 week

• Neck pain intensity

  Visual analog scale (VAS) was used to neck pain intensity during resting and activity.

  4 week

Secondary Outcomes (6)

• Craniocervical Flexion Test (CCFT)

  4 week

• Cervical flexor muscle endurance

  4 week

• Cervical extensor muscle endurance

  4 week

• Dynamic balance

  4 week

• Static balance

  4 week

Study Arms (3)

Conventional physiotherapy

EXPERIMENTAL

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.

Other: Conventional physiotherapy

Muscle Energy Technique (MET)

EXPERIMENTAL

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.

Other: Conventional physiotherapy and Muscle Energy Technique

Cervical Mobilization Techniques (CMT)

EXPERIMENTAL

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.

Other: Conventional physiotherapy and Cervical Mobilization Techniques

Interventions

Conventional physiotherapy 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.

Conventional physiotherapy

Conventional physiotherapy and Muscle Energy Technique 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.

Muscle Energy Technique (MET)

Conventional physiotherapy and Cervical Mobilization Techniques 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.

Cervical Mobilization Techniques (CMT)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Buse Sezerel

Famagusta, 99628, Cyprus

Location

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• İNCİ YÜKSEL, Prof. Dr.

  Eastern Mediterranean University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: March 2, 2021
• Study Start: May 12, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CY (1)