Cervical SpondylosisNCT04777318
Comparison of the Effects of Different Manual Therapy Techniques in Patients With Cervical Spondylosis
A study testing Conventional physiotherapy, Conventional physiotherapy and Muscle Energy Technique and Conventional physiotherapy and Cervical Mobilization Techniques in people with Cervical Spondylosis, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Conventional physiotherapy, Conventional physiotherapy and Muscle Energy Technique and Conventional physiotherapy and Cervical Mobilization Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteCyprus
- Study dates
- 12 May 2021to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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 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
- Cervical Spondylosis
- Being tested
- Conventional physiotherapy, Conventional physiotherapy and Muscle Energy Technique, Conventional physiotherapy and Cervical Mobilization Techniques
- Keywords
- Cervical Spondylosis, Proprioception, Manual Therapies
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
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 and Muscle Energy TechniqueOther
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.
Conventional physiotherapy and Cervical Mobilization TechniquesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Conventional physiotherapy and Cervical Mobilization Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 week
Neck pain intensity
Visual analog scale (VAS) was used to neck pain intensity during resting and activity.
Measured: 4 week
Secondary outcomes (6)
Craniocervical Flexion Test (CCFT)
CCFT is used to evaluate the activation and static endurance of the deep flexor muscles of the cervical region. CCFT is also defined as the motor control test of the cervical region. The test was performed using Stabilizer Pressure Biofeedback (Chattanooga Stabilizer). The patient was positioned in the supine position, with the cervical region in neutral position and the biofeedback pressure unit was placed in the suboccipital space. The pressure cell was inflated to 20 mmHg in order to support cervical lordosis. Then, the individual was instructed to perform a posterior tilt movement by increasing the pressure at 5 different levels (22, 24, 26, 28 and 30 mmHg.), by following the monitor of the device. After teaching the movement, the person was asked to perform 10 contractions lasting 10 seconds at each level. The person moved the next level after each successful attempt and was given a 10-second rest period between repetitions.
Measured: 4 week
Cervical flexor muscle endurance
Cervical flexor muscle endurance was evaluated with the patient lying in the supine position with the knees flexed. The person was asked to press their chin back and lift their head approximately 2.5 cm from the bed while maintaining this position. The time the individual maintained the position was recorded in seconds.
Measured: 4 week
Cervical extensor muscle endurance
The cervical extensor muscle endurance was evaluated with the patient lying face down and the head hanging from the bed. A belt was passed over the ears of the individuals and weight was tied at the end. The weight was been 2.32 kg for women and 4 kg for men. The individual was asked to bring his head to a neutral position and to maintained this position. The time the individual maintained the position was recorded in seconds.
Measured: 4 week
Dynamic balance
It was evaluated using the Y balance test. The reach distance in the anterior, posteromedial and posterolateral transport directions were recorded. People was 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 were recorded. Mixed reach distance; was calculated using the formula [(maximum anterior + maximum posteromedial + maximum posterolateral) / (3 x lower extremity length)] x 100.
Measured: 4 week
Static balance
It was evaluated with both eyes closed and eyes open using the single leg balance test (SLBT). Individuals was asked to cross their arms at chest level and focus on a point on the wall. The test started when the foot was lifted off the ground and the time it remained in this position was recorded in seconds using a stopwatch.
Measured: 4 week
Neck pain related disability
The Copenhagen Neck Functional Scale (KBFSÖ) is a scale evaluating the effect of neck pain related disability. 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. The questions were answered individually as yes (0 points), sometimes (1 point) and no (2 points). The total score was recorded for use in analysis.
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start12 May 2021
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buse Sezerel, Eastern Mediterranean University
- Investigators
- İNCİ YÜKSEL, Prof. Dr., Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04777318
- Sponsor's protocol ID
- 2020-0041
- Status last verified
- Oct 2023
- First submitted
- 19 Feb 2021
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04777318
- Acronym / sponsor ID
- 2020-0041
- Conditions
- Cervical Spondylosis
- Keywords
- Cervical Spondylosis, Proprioception, Manual Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional physiotherapy | Experimental | Other: Conventional physiotherapyThe individuals in the control group was taken in a total of 12 sessions of conventional physiotherapy program for 4 weeks, 3 days a week. |
| Muscle Energy Technique (MET) | Experimental | Other: Conventional physiotherapy and Muscle Energy TechniqueIn 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. |
| Cervical Mobilization Techniques (CMT) | Experimental | Other: Conventional physiotherapy and Cervical Mobilization TechniquesIn 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapyA 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. | Other | Conventional physiotherapy |
| Conventional physiotherapy and Muscle Energy TechniqueIn 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. | Other | Muscle Energy Technique (MET) |
| Conventional physiotherapy and Cervical Mobilization TechniquesCervical 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. | Other | Cervical Mobilization Techniques (CMT) |
Primary outcome
Neutral head position test (NBPT)
Time frame: 4 week
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.
Target head position test (HBPT)
Time frame: 4 week
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.
Cervical region movement sensation
Time frame: 4 week
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.
Neck pain intensity
Time frame: 4 week
Visual analog scale (VAS) was used to neck pain intensity during resting and activity.
6 secondary outcomes
Craniocervical Flexion Test (CCFT)
Time frame: 4 week
Cervical flexor muscle endurance
Time frame: 4 week
Cervical extensor muscle endurance
Time frame: 4 week
Dynamic balance
Time frame: 4 week
Static balance
Time frame: 4 week
Neck pain related disability
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İNCİ YÜKSEL, Prof. Dr. study director
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy, Conventional physiotherapy and Muscle Energy Technique and Conventional physiotherapy and Cervical Mobilization Techniques in people with Cervical Spondylosis, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutral head position test (NBPT) (time frame: 4 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.