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

Primary Purpose

Cervical Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Conventional physiotherapy
Conventional physiotherapy and Muscle Energy Technique
Conventional physiotherapy and Cervical Mobilization Techniques
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis focused on measuring Cervical Spondylosis, Proprioception, Manual Therapies

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Buse SezerelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional physiotherapy

Muscle Energy Technique (MET)

Cervical Mobilization Techniques (CMT)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Neutral head position test (NBPT)
NBPT will be evaluated using the CROM (cervical range of motion) device, which is a special goniometer for the neck. NBPT will be started when the cervical region is in a neutral position, the individual will be asked to turn his head completely to the left or right and return to the neutral position in a controlled manner. The angular difference will be recorded in degrees.
Target head position test (HBPT)
CROM device will be used for HBPT evaluation. The researcher will passively move the person's head to the pre-determined target position, 50% of the maximum range of motion. The head will be kept in the target position for 3 seconds (sec), then the person will be asked to move the head to the neutral position first and then actively move it back to the target position. The angular difference will be recorded in degrees.
Cervical region movement sensation
The LASER-Pointer will be fixed on the head of the individual. The person will be 1 m from ZZ-pattern transferred to A4 paper of 13 cm height with 23.4 horizontal, 26.6 long diagonal lines. will sit on the chair away. The pattern has five thin additional lines every 5 mm from the baseline to differentiate the five deviation zones. The test will be 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 will be considered complete when it returns to its starting position. After the test, video files will be examined at 1/8 of the normal speed, to be used in analysis; time, error frequency and error size will be calculated.

Secondary Outcome Measures

Craniocervical Flexion Test (CCFT)
CCFT is used to evaluate the activation and static endurance of the deep flexor muscles of the cervical region. KSFT is also defined as the motor control test of the cervical region. The test will be performed using Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). The patient will be positioned in the supine position, with the cervical region in neutral position and the biofeedback pressure unit will be placed in the suboccipital space. The pressure cell will be inflated to 20 mmHg in order to support cervical lordosis. Then, the individual will be instructed to perform a posterior tilt movement by increasing the pressure at 5 different levels (22, 24, 26, 28 and 30 mmHg.), Following the monitor of the device. After teaching the movement, the person will be asked to perform 10 contractions lasting 10 seconds at each level. The person will move to the next level after each successful attempt and will be given a 10-second rest period between repetitions.
Cervical flexor muscle endurance
Cervical flexor muscle endurance will be evaluated with the patient lying in the supine position with the knees flexed. The person will be asked to press their chin back and lift their head approximately 2.5 cm from the bed while maintaining this position. The amount of time the individual holds the position will be recorded in seconds.
Cervical extensor muscle endurance
The cervical extensor muscle endurance will be evaluated with the patient lying face down and the head hanging from the bed. A belt will be passed over the ears of the individuals and weight will be tied at the end. The weight will be 2.32 kg for women and 4 kg for men. The individual will be asked to bring his head to a neutral position and to maintain this position. The time the position can be maintained will be recorded in seconds.
Dynamic balance
It will be evaluated using the Y balance test. The reach distance in the anterior, posteromedial and posterolateral transport directions will be recorded. People will be asked to reach the furthest point with the other foot while trying to maintain balance with the dominant foot on the wooden platform while the hands are on the waist. 3 repetitions of reaching out in 3 directions will be recorded. Mixed reach distance; It will be calculated using the formula [(maximum anterior + maximum posteromedial + maximum posterolateral) / (3 x lower extremity length)] x 100.
Static balance
It will be evaluated with both eyes closed and eyes open using the single leg balance test (SLBT). Individuals will be asked to cross their arms at chest level and focus on a point on the wall. When the foot is lifted from the ground, the test will be started, the time it has kept in position will be recorded in seconds using a stopwatch.
Neck pain
The Copenhagen Neck Functional Scale (KBFSÖ) is a scale evaluating the effect of neck pain. It has excellent internal consistency and test-retest reliability and good validity with pain scale. The scale consists of 15 items. The total score of the questionnaire can range from 0 (no neck pain effect) to 30 (worst possible effect). Items 1 and 5 directly assess pain intensity; Items 2, 3, 4, 5, 7, 8, 9, and 10 assess disability during daily activities; and Articles 6, 9, 11, 13 and 14 focus on social interactions and recreational activities. The last item 15 evaluates the patient's perception of the future impact of neck pain. Questions will be answered individually with yes (0 point), sometimes (1 point) and no (2 points).

Full Information

First Posted
February 19, 2021
Last Updated
February 21, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT04777318
Brief Title
Comparison of the Effects of Different Manual Therapy Techniques in Patients With Cervical Spondylosis
Official Title
Comparison of the Effects of Muscle Energy Technique and Mobilization Techniques on Cervical Proprioception and Motor Control in Patients With Cervical Spondylosis: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

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

5. Study Description

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 is 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
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 will be useful to investigate the effect of MET, which includes active muscle contractions of the patient, on the proprioceptive sensation and to compare the results with more passive applications (manipulation or mobilization) in terms of determining the optimal treatment method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis
Keywords
Cervical Spondylosis, Proprioception, Manual Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
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 95 people.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional physiotherapy
Arm Type
Experimental
Arm Description
The individuals in the control group will be included in a total of 12 sessions of conventional physiotherapy program for 4 weeks, 3 days a week.
Arm Title
Muscle Energy Technique (MET)
Arm Type
Experimental
Arm Description
In addition to the conventional physiotherapy program of 12 sessions for 4 weeks, 3 days a week, muscle energy technique will be applied to the individuals in the second group.
Arm Title
Cervical Mobilization Techniques (CMT)
Arm Type
Experimental
Arm Description
In the third group, cervical mobilization techniques will be applied in addition to the conventional physiotherapy program for a total of 12 sessions for 4 weeks, 3 days a month.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
A total of 12 sessions of conventional physiotherapy program for 4 weeks will be applied 3 days a week. The conventional physiotherapy program will include 20 min hotpack , 10 min ultrasound, 20 min conventional (Transcutaneous electrical nerve stimulation) TENS application.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy and Muscle Energy Technique
Intervention Description
In addition to conventional therapy, the muscle energy technique will be applied to the individuals in the second group at the same frequency. Muscle energy technique will be applied to the upper trapezius, sternocleidomastoideus , scalene (anterior-medius-posterior) and levator scapula muscles. According to the MET post-isometric relaxation method, each muscle will be applied as one set (each set includes three repetitions). The patient will be asked to perform a 7-second isometric contraction corresponding to 20% of the maximum isometric contraction force in the area where the limitation is felt. After the application, the patient will be asked to breathe and relax. The stretching will be kept beyond the resistance barrier for 30 seconds and then the technique will be repeated by taking the neck back to the barrier point.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy and Cervical Mobilization Techniques
Intervention Description
Cervical mobilization techniques will be 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 will be 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 will be applied. Vertebrobasilar Insufficiency Test will be applied to all participants to determine the appropriateness of cervical mobilization. Before mobilization, a deep friction massage will be applied on painful spasmic nuchal muscles for 3-4 minutes in order to increase blood circulation and relax tense tissues.
Primary Outcome Measure Information:
Title
Neutral head position test (NBPT)
Description
NBPT will be evaluated using the CROM (cervical range of motion) device, which is a special goniometer for the neck. NBPT will be started when the cervical region is in a neutral position, the individual will be asked to turn his head completely to the left or right and return to the neutral position in a controlled manner. The angular difference will be recorded in degrees.
Time Frame
4 week
Title
Target head position test (HBPT)
Description
CROM device will be used for HBPT evaluation. The researcher will passively move the person's head to the pre-determined target position, 50% of the maximum range of motion. The head will be kept in the target position for 3 seconds (sec), then the person will be asked to move the head to the neutral position first and then actively move it back to the target position. The angular difference will be recorded in degrees.
Time Frame
4 week
Title
Cervical region movement sensation
Description
The LASER-Pointer will be fixed on the head of the individual. The person will be 1 m from ZZ-pattern transferred to A4 paper of 13 cm height with 23.4 horizontal, 26.6 long diagonal lines. will sit on the chair away. The pattern has five thin additional lines every 5 mm from the baseline to differentiate the five deviation zones. The test will be 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 will be considered complete when it returns to its starting position. After the test, video files will be examined at 1/8 of the normal speed, to be used in analysis; time, error frequency and error size will be calculated.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Craniocervical Flexion Test (CCFT)
Description
CCFT is used to evaluate the activation and static endurance of the deep flexor muscles of the cervical region. KSFT is also defined as the motor control test of the cervical region. The test will be performed using Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). The patient will be positioned in the supine position, with the cervical region in neutral position and the biofeedback pressure unit will be placed in the suboccipital space. The pressure cell will be inflated to 20 mmHg in order to support cervical lordosis. Then, the individual will be instructed to perform a posterior tilt movement by increasing the pressure at 5 different levels (22, 24, 26, 28 and 30 mmHg.), Following the monitor of the device. After teaching the movement, the person will be asked to perform 10 contractions lasting 10 seconds at each level. The person will move to the next level after each successful attempt and will be given a 10-second rest period between repetitions.
Time Frame
4 week
Title
Cervical flexor muscle endurance
Description
Cervical flexor muscle endurance will be evaluated with the patient lying in the supine position with the knees flexed. The person will be asked to press their chin back and lift their head approximately 2.5 cm from the bed while maintaining this position. The amount of time the individual holds the position will be recorded in seconds.
Time Frame
4 week
Title
Cervical extensor muscle endurance
Description
The cervical extensor muscle endurance will be evaluated with the patient lying face down and the head hanging from the bed. A belt will be passed over the ears of the individuals and weight will be tied at the end. The weight will be 2.32 kg for women and 4 kg for men. The individual will be asked to bring his head to a neutral position and to maintain this position. The time the position can be maintained will be recorded in seconds.
Time Frame
4 week
Title
Dynamic balance
Description
It will be evaluated using the Y balance test. The reach distance in the anterior, posteromedial and posterolateral transport directions will be recorded. People will be asked to reach the furthest point with the other foot while trying to maintain balance with the dominant foot on the wooden platform while the hands are on the waist. 3 repetitions of reaching out in 3 directions will be recorded. Mixed reach distance; It will be calculated using the formula [(maximum anterior + maximum posteromedial + maximum posterolateral) / (3 x lower extremity length)] x 100.
Time Frame
4 week
Title
Static balance
Description
It will be evaluated with both eyes closed and eyes open using the single leg balance test (SLBT). Individuals will be asked to cross their arms at chest level and focus on a point on the wall. When the foot is lifted from the ground, the test will be started, the time it has kept in position will be recorded in seconds using a stopwatch.
Time Frame
4 week
Title
Neck pain
Description
The Copenhagen Neck Functional Scale (KBFSÖ) is a scale evaluating the effect of neck pain. It has excellent internal consistency and test-retest reliability and good validity with pain scale. The scale consists of 15 items. The total score of the questionnaire can range from 0 (no neck pain effect) to 30 (worst possible effect). Items 1 and 5 directly assess pain intensity; Items 2, 3, 4, 5, 7, 8, 9, and 10 assess disability during daily activities; and Articles 6, 9, 11, 13 and 14 focus on social interactions and recreational activities. The last item 15 evaluates the patient's perception of the future impact of neck pain. Questions will be answered individually with yes (0 point), sometimes (1 point) and no (2 points).
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BUSE SEZEREL, MSc
Phone
9005338405101
Email
busesezerel@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
İNCİ YÜKSEL, Prof. Dr.
Phone
+903926303067
Email
inci.yuksel@emu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İNCİ YÜKSEL, Prof. Dr.
Organizational Affiliation
Eastern Mediterranean University
Official's Role
Study Director
Facility Information:
Facility Name
Buse Sezerel
City
Famagusta
ZIP/Postal Code
99628
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ZEHRA GÜÇHAN TOPÇU
Phone
+903926303067
Ext
2496
Email
zehra.guchan@emu.edu.tr

12. IPD Sharing Statement

Learn more about this trial

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

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