Neck PainNCT06200038
Effect of Manual Therapy on Non Specific Neck Pain
A study testing Mulligan Reverse Natural Apophysial Glide Technique (RNAGS) and Conventional physical therapy in people with Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effects of Mulligan concept Reverse Natural Apophysial Glide Technique (RNAGS)technique applied to the thoracic region on pain, limitation of movement, and functionality in individuals with mechanical neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Mulligan Reverse Natural Apophysial Glide Technique (RNAGS) and Conventional physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 May 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those between the ages of 18-65
- Those with neck pain lasting at least 3 months
- Individuals diagnosed with mechanical neck pain by a specialist physician
Who cannot join
- Those with a history of spinal surgery
- Those with a history of whiplash injury
- Those with a history of trauma in the cervical and thoracic region
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences Bolu Abant İzzet Baysal University
Bolu, 14300
About this study
Official title: Effects of Upper Thoracic Mulligan Mobilization for Pain, Range of Motion and Function in Patients With Mechanical Neck Pain
The aim of this study is to investigate the effects of Mulligan concept Reverse Natural Apophysial Glide Technique (RNAGS)technique applied to the thoracic region on pain, limitation of movement, and functionality in individuals with mechanical neck pain.
Read the detailed description
When we look at the studies investigating the effectiveness of different treatment modalities in non-specific neck pain (NSNP), there is no method accepted as the gold standard for the treatment of NSNP. One of the preferred treatment options for NSNP is physiotherapy and rehabilitation. Physiotherapy and rehabilitation includes electrotherapy modalities, therapeutic exercises, joint mobilisation and manipulations, myofascial release. Among these treatments, manual therapy, which targets the harmony of structure and function, is one of the most preferred treatment methods by physiotherapists. Manual therapy provides improvement by orienting the body's biomechanics, circulation and body structure by directly affecting the joints, muscles and soft tissues. In the literature, there are studies on both cervical mobilisation and thoracic mobilisation for neck pain. Cervical mobilisation and manipulation in neck pain are controversial because they carry certain risks. It has been reported that mobilisation of the thoracic spine decreases pain in the cervical region and increases mobilisation in this region. When the literature was examined, there was no study examining the effect of the Mulligan concept natural apophyseal reversal technique applied to the thoracic region on NSNP. This study was planned to investigate the effect of natural apophyseal reversal on pain and mobility limitation in individuals diagnosed with NSNP.
- Conditions
- Neck Pain
- Being tested
- Mulligan Reverse Natural Apophysial Glide Technique (RNAGS), Conventional physical therapy and sham manual therapy, Conventional physical therapy
- Keywords
- Mechanical Neck Pain, Thoracic Mobilization, Mulligan, Range of Motion
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Reverse Natural Apophysial Glide Technique (RNAGS)Other
Also called TENS, Hotpack, Utrasound, Stretching exercises
Mulligan mobilization techniques was applied to the upper thoracic segments with the RNAGS technique. The application was performed with one hand (thumb in extension, other fingers flexed) that was used to perform the pushing maneuver on the transverse processes, while the other arm was used to gently grasp the head of the patient and recline the neck against the body for stabilization.
Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist.
Conventional physical therapy and sham manual therapyOther
Also called TENS, Hotpack, Utrasound, Stretching exercises
A sham Mulligan RNAGS technique with low pressure compression was applied to thoracic region.
Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist.
Conventional physical therapyOther
Also called TENS, Hotpack, Utrasound, Stretching exercises
Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Mulligan group (MG) | Experimental | Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional transcutaneous electrical nerve stimulation (TENS) was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.In addition to physiotherapy applications in MG, Mulligan natural apophyseal reversal technique was applied to the upper thoracic segments. Mulligan mobilization was performed with 3 sets of 10 repetitions and 15-20 seconds of rest between sets. Receives: Other: Mulligan Reverse Natural Apophysial Glide Technique (RNAGS) |
| Sham (different in the direction and amplitude of mobilization) group | Sham comparator | Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.Sham mobilization was applied to the segments where Mulligan mobilization was carried out in Sham group, in which the direction of thrust and thrust were different. Receives: Other: Conventional physical therapy and sham manual therapy |
| Physiotherapy group | Other | Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist. Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Range of Motion Assessment (ROM)
Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
Measured: 3 weeks
Pain Assessment
Visual analogue scale (VAS) was used to assess the severity of mechanical neck pain. Individuals were asked to mark the pain they felt on a 10 cm long VAS scale ("0" indicates no pain and "10" indicates unbearable pain).
Measured: 3 weeks
Neck Disability Status Assessment (NDI)
Evaluate neck disability status A questionnaire consisting of 10 items. Seven items are related to activities of daily living, two are related to pain intensity and one is related to concentration. The response to each item is scored between 0 (no limitation) and 5 (maximum limitation) and the final NDI score is obtained by summing each score
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2021
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Osman Pala, Abant Izzet Baysal University
- Investigators
- Omer Osman PALA, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200038
- Sponsor's protocol ID
- AIBU-FTR-ÖOP-07
- Status last verified
- Dec 2023
- First submitted
- 29 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan for data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Thoracic Mulligan Mobilization for Pain, Range of Motion and Function in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT06200038
- Acronym / sponsor ID
- AIBU-FTR-ÖOP-07
- Conditions
- Neck Pain
- Keywords
- Mechanical Neck Pain, Thoracic Mobilization, Mulligan, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 10 Jan 2024 (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.
The aim of this study is to investigate the effects of Mulligan concept Reverse Natural Apophysial Glide Technique (RNAGS)technique applied to the thoracic region on pain, limitation of movement, and functionality in individuals with mechanical neck pain.
Detailed description
When we look at the studies investigating the effectiveness of different treatment modalities in non-specific neck pain (NSNP), there is no method accepted as the gold standard for the treatment of NSNP. One of the preferred treatment options for NSNP is physiotherapy and rehabilitation. Physiotherapy and rehabilitation includes electrotherapy modalities, therapeutic exercises, joint mobilisation and manipulations, myofascial release. Among these treatments, manual therapy, which targets the harmony of structure and function, is one of the most preferred treatment methods by physiotherapists. Manual therapy provides improvement by orienting the body's biomechanics, circulation and body structure by directly affecting the joints, muscles and soft tissues. In the literature, there are studies on both cervical mobilisation and thoracic mobilisation for neck pain. Cervical mobilisation and manipulation in neck pain are controversial because they carry certain risks. It has been reported that mobilisation of the thoracic spine decreases pain in the cervical region and increases mobilisation in this region. When the literature was examined, there was no study examining the effect of the Mulligan concept natural apophyseal reversal technique applied to the thoracic region on NSNP. This study was planned to investigate the effect of natural apophyseal reversal on pain and mobility limitation in individuals diagnosed with NSNP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan group (MG) | Experimental | Other: Mulligan Reverse Natural Apophysial Glide Technique (RNAGS)Individuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional transcutaneous electrical nerve stimulation (TENS) was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.In addition to physiotherapy applications in MG, Mulligan natural apophyseal reversal technique was applied to the upper thoracic segments. Mulligan mobilization was performed with 3 sets of 10 repetitions and 15-20 seconds of rest between sets. |
| Sham (different in the direction and amplitude of mobilization) group | Sham comparator | Other: Conventional physical therapy and sham manual therapyIndividuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist.Sham mobilization was applied to the segments where Mulligan mobilization was carried out in Sham group, in which the direction of thrust and thrust were different. |
| Physiotherapy group | Other | Other: Conventional physical therapyIndividuals underwent 11 sessions (every day for the first week, every other day for the next two weeks).Hot pack was applied to the neck and upper trapezius area for 20 minutes.2 channels and 4 electrodes in the neck area; Conventional TENS was applied to the patient for 20 minutes with current transition time: 50-100 microseconds, frequency: 60-120 Hz and mild tingling without causing discomfort.US application was performed at a frequency of 1.5 W/cm2 and 1 Mhz for 8 minutes.Stretching exercises were applied to the trapezius upper part and levator scapula muscles for 15-30 seconds with 10 repetitions under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those between the ages of 18-65
- Those with neck pain lasting at least 3 months
- Individuals diagnosed with mechanical neck pain by a specialist physician
Key exclusion criteria (4 listed)
- Those with a history of spinal surgery
- Those with a history of whiplash injury
- Those with a history of trauma in the cervical and thoracic region
- Pregnancy
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 |
|---|---|---|
| Mulligan Reverse Natural Apophysial Glide Technique (RNAGS)Also: TENS, Hotpack, Utrasound, Stretching exercisesMulligan mobilization techniques was applied to the upper thoracic segments with the RNAGS technique. The application was performed with one hand (thumb in extension, other fingers flexed) that was used to perform the pushing maneuver on the transverse processes, while the other arm was used to gently grasp the head of the patient and recline the neck against the body for stabilization. Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist. | Other | Mulligan group (MG) |
| Conventional physical therapy and sham manual therapyAlso: TENS, Hotpack, Utrasound, Stretching exercisesA sham Mulligan RNAGS technique with low pressure compression was applied to thoracic region. Conventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist. | Other | Sham (different in the direction and amplitude of mobilization) group |
| Conventional physical therapyAlso: TENS, Hotpack, Utrasound, Stretching exercisesConventional TENS was applied to the neck area with 2 channels and 4 electrodes for 20 min (current passage time: 50-100 microseconds, frequency: 0-120 Hz). Ultrasonography was performed for 8 minutes with an intensity of 1.5 w/cm2 and a frequency of 1 MHz. Stretching exercises were applied to the upper part of the trapezius and levator scapula muscles for 15-30 seconds for 10 repetitions by a physiotherapist | Other | Physiotherapy group |
Primary outcome
Joint Range of Motion Assessment (ROM)
Time frame: 3 weeks
Active flexion, extension, right/left lateral flexion and rotation of the cervical region were measured in the sitting position with a phone goniometer application.
Pain Assessment
Time frame: 3 weeks
Visual analogue scale (VAS) was used to assess the severity of mechanical neck pain. Individuals were asked to mark the pain they felt on a 10 cm long VAS scale ("0" indicates no pain and "10" indicates unbearable pain).
Neck Disability Status Assessment (NDI)
Time frame: 3 weeks
Evaluate neck disability status A questionnaire consisting of 10 items. Seven items are related to activities of daily living, two are related to pain intensity and one is related to concentration. The response to each item is scored between 0 (no limitation) and 5 (maximum limitation) and the final NDI score is obtained by summing each score
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 10 Jan 2024.
- Individual participant dataSharing planned: No. There is no plan for data sharing.
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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.
Omer Osman PALA, PhD principal investigator
Abant Izzet Baysal 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 Mulligan Reverse Natural Apophysial Glide Technique (RNAGS) and Conventional physical therapy in people with Neck Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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 10 Jan 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Joint Range of Motion Assessment (ROM) (time frame: 3 weeks). The study lists 3 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 10 Jan 2024.