Neck PainNCT06460532
Effects of Diaphragm Manual Therapy Verses Sustained Natural Apophyseal Glide in Mechanical Neck Pain
A study testing Baseline treatment in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Baseline treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jun 2024to 10 Oct 2024
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group between 18 and 40 years
- Both gender male and female
- Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy
- Pain reported on NPRS score ˃3 to <7/10 in neck region for more than 3 months.
- Limited Neck ROM
- Negative Spurling's test, traction test, upper limb tension test, and shoulder abduction test
Who cannot join
- Patients were excluded if they were diagnosed with the following conditions for ˃6 months
- Tuberculosis, carcinoma, heart disease, and osteoporosis
- Neural disorders due to prolapsed intervertebral disc
- Any trauma or localized infection in neck region
- Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint
- Hyper flexibility
Show all 11Show fewer
- Open sores
- Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
- Psychiatric diseases such as phobia/obsession and depression
- Allergy to hot pack
- Patients with history of surgery in cervical spine region with in a year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diaphragm Manual Therapy Versus Sustained Natural Apophyseal Glide on Pain, Range of Motion and Functional Disability in Patients With Mechanical Neck Pain
Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.
Read the detailed description
This project will be a Randomized Clinical Trial conducted to check the effects of Diaphragm manual therapy versus sustained natural apophyseal glide on pain, range of motion and functional disability in patients with mechanical neck pain at Sehat Medical Complex Lahore through non-probability convenient sampling technique on 34 patients will be allocated using simple random sampling through Computer generated Randomization into Group A and Group B. Group A will be treated with Diaphragm Manual Therapy and baseline treatment was given and Group B with Sustained Natural Apophyseal Glide and baseline treatment was given. All Exercise were performed 3 times a week for total 4 weeks. Outcome measures will be conducted through NPRS for pain, ROM measured by Goniometer, and Neck Disability Index (NDI) for Disability after 4 weeks. Data was analyzed during SPSS software version 25. After assessing the normality of data by the Shapiro-Wilk test, it decided whether either parametric or non-parametric tests were used within a group or between two groups.
- Conditions
- Neck Pain
- Being tested
- Baseline treatment
- Keywords
- disability, muscle strength, pain, Range of Motion
- Medical subject headings
- Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline treatmentOther
Transcutaneous Electric Nerve Stimulation (TENS) of Care Vision company will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Diaphragm Manual Therapy | Experimental | Group A were receiving diaphragm Manual therapy by Leon Chaitow. Subsequently, in order to indirectly stretch and mobilize the fibres of the diaphragm, diaphragmatic manual therapy was used, which should result in improved muscle contraction and reduced tension. The doming diaphragmatic technique and the manual diaphragmatic release technique, both as described by Leon Chaitow, will be among the experimental methods employed. For 10 min, both manoeuvres were performed in 2 sets of 10 repetitions each, separated by 1 min. Receives: Other: Baseline treatment |
| Group B: Sustained Natural Apophyseal Glide (SNAGs) | Active comparator | Group B has received the Sustained natural apophyseal glide (SNAGS). Treatment procedure for SNAGs was sustained natural apophyseal glides whereby the patient attempts to actively move a painful or stiff joint through its ROM while the therapist overlays an accessory glide parallel with the treatment plane. SNAG mobilization was given to a patient (as defined by Mulligan) sitting on a chair. At the same time, the treating physiotherapist stood behind by placing the medial border of the distal phalanx of the thumb on the spine of one vertebra above the affected region. The glides were given with the tip of the thumb placed at an angle of 45° along the eyeball direction reinforced by another thumb. In the session, glides were repeated six times, and three sets were given at C3-C7 cervical levels. Receives: Other: Baseline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95
Measured: upto 4 weeks
Neck disability Index (NDI)
Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98.
Measured: upto 4 weeks
Universal Goniometer
An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer.
Measured: upto 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start30 Jun 2024
- Primary completion30 Sep 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anam Akram, MSPT*, Principal investigator, Riphah International University,Lahoresamrood Akram, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460532
- Sponsor's protocol ID
- REC/RCR & AHS/23/0196 Anam
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saleem I, Zahoor IA, Rana AA, Sarfraz S, Ibrahim M, Ghaffar N. Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects on Pain, Range of Motion and Neck Disability in Patients with Chronic Neck Pain: Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects. Pakistan Journal of Health Sciences. 2022:154-8.
Tatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Manual Therapy in the Cervical Spine and Diaphragm, in Combination with Breathing Reeducation Exercises, in Patients with Non-Specific Chronic Neck Pain: Protocol for Development of Outcome Measures and a Randomized Controlled Trial. Diagnostics (Basel). 2022 Nov 4;12(11):2690. doi: 10.3390/diagnostics12112690.
PubMed 36359533Pal A, Misra A. EFFECTIVENESS OF SNAG MOBILIZATION ON COMPUTER PROFES-SIONALS WITH MECHANICAL NECK PAIN AND MOBILITY DEFICIT. Int J Physiother Res. 2019;7(2):3022-27.
Haghighat F, Moradi R, Rezaie M, Yarahmadi N, Ghaffarnejad F. Added value of diaphragm myofascial release on forward head posture and chest expansion in women with symptomatic forward head posture: A randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:645-651. doi: 10.1016/j.jbmt.2025.07.015. Epub 2025 Aug 8.
PubMed 41316631Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16.
PubMed 33992285Jabbar KM, Gandomi F. The comparison of two corrective exercise approaches for hyperkyphosis and forward head posture: A quasi-experimental study. J Back Musculoskelet Rehabil. 2021;34(4):677-687. doi: 10.3233/BMR-200160.
PubMed 33896809Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
PubMed 32723399
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diaphragm Manual Therapy Versus Sustained Natural Apophyseal Glide on Pain, Range of Motion and Functional Disability in Patients With Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT06460532
- Acronym / sponsor ID
- REC/RCR & AHS/23/0196 Anam
- Conditions
- Neck Pain
- Keywords
- disability, muscle strength, pain, Range of Motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 14 Jun 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.
Mechanical neck pain is defined as pain and discomfort localized between the superior nuchal line, cervical spine, and the spinous process of the first thoracic vertebra. Some of the most typical factors include continuous use of mobile phones and computers, working in sedentary jobs, etc. Study aimed to compare diaphragm manual therapy and Sustained Natural Apophyseal Glide on pain, range of motion and functional disability in patients with mechanical neck pain.
Detailed description
This project will be a Randomized Clinical Trial conducted to check the effects of Diaphragm manual therapy versus sustained natural apophyseal glide on pain, range of motion and functional disability in patients with mechanical neck pain at Sehat Medical Complex Lahore through non-probability convenient sampling technique on 34 patients will be allocated using simple random sampling through Computer generated Randomization into Group A and Group B. Group A will be treated with Diaphragm Manual Therapy and baseline treatment was given and Group B with Sustained Natural Apophyseal Glide and baseline treatment was given. All Exercise were performed 3 times a week for total 4 weeks. Outcome measures will be conducted through NPRS for pain, ROM measured by Goniometer, and Neck Disability Index (NDI) for Disability after 4 weeks. Data was analyzed during SPSS software version 25. After assessing the normality of data by the Shapiro-Wilk test, it decided whether either parametric or non-parametric tests were used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Diaphragm Manual Therapy | Experimental | Other: Baseline treatmentGroup A were receiving diaphragm Manual therapy by Leon Chaitow. Subsequently, in order to indirectly stretch and mobilize the fibres of the diaphragm, diaphragmatic manual therapy was used, which should result in improved muscle contraction and reduced tension. The doming diaphragmatic technique and the manual diaphragmatic release technique, both as described by Leon Chaitow, will be among the experimental methods employed. For 10 min, both manoeuvres were performed in 2 sets of 10 repetitions each, separated by 1 min. |
| Group B: Sustained Natural Apophyseal Glide (SNAGs) | Active comparator | Other: Baseline treatmentGroup B has received the Sustained natural apophyseal glide (SNAGS). Treatment procedure for SNAGs was sustained natural apophyseal glides whereby the patient attempts to actively move a painful or stiff joint through its ROM while the therapist overlays an accessory glide parallel with the treatment plane. SNAG mobilization was given to a patient (as defined by Mulligan) sitting on a chair. At the same time, the treating physiotherapist stood behind by placing the medial border of the distal phalanx of the thumb on the spine of one vertebra above the affected region. The glides were given with the tip of the thumb placed at an angle of 45° along the eyeball direction reinforced by another thumb. In the session, glides were repeated six times, and three sets were given at C3-C7 cervical levels. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age group between 18 and 40 years
- Both gender male and female
- Individuals having localized pain or stiffness in the cervical spine or both combined between C3 and C7 without upper-limb radiculopathy
- Pain reported on NPRS score ˃3 to <7/10 in neck region for more than 3 months.
- Limited Neck ROM
Key exclusion criteria (11 listed)
- Patients were excluded if they were diagnosed with the following conditions for ˃6 months
- Tuberculosis, carcinoma, heart disease, and osteoporosis
- Neural disorders due to prolapsed intervertebral disc
- Any trauma or localized infection in neck region
- Upper motor neuron disease, cervical stenosis, and metabolic diseases in bone and joint
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 |
|---|---|---|
| Baseline treatmentTranscutaneous Electric Nerve Stimulation (TENS) of Care Vision company will be applied, with a pulse duration of 250 microseconds at a frequency of 80 Hz for 15 min in the suboccipital region and the trapezius bilaterally. | Other | Group A: Diaphragm Manual Therapy, Group B: Sustained Natural Apophyseal Glide (SNAGs) |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: upto 4 weeks
The primary outcome was pain assessment by the Numeric Pain Rating Scale (NPRS). This is a reliable self-reported 11-point numeric scale, where each number reflects the intensity of the pain referred by the patient: "0" stands for "no pain" and "10" for "the worst possible pain". Patients verbally selected 3 values that were most in line with the intensity of pain that they had experienced in the previous 24 h, corresponding to current pain and to his/her best and worst pain. The average of the 3 ratings was used to represent the patient's level of pain over the previous 24 h. NPRS was assessed before and after each treatment session. The reliability is (r = 0.96 and 0.95, respectively) and validity correlations range from 0.86 to 0.95
Neck disability Index (NDI)
Time frame: upto 4 weeks
Disability was assessed using the Urdu version of the Neck Disability Index (NDI). This is a reliable scale and was self-assessed by the patients and filled in at the beginning and at the end of the whole treatment. The results of this questionnaire have been utilized to evaluate the disability. It consists of 10 items: 7 linked to activities of daily living, 2 to pain, and 1 to concentration. From 0 to 5, each item received a score. Higher scores corresponded to more disability, and the total score was reported as a percentage. The reliability is between 0.50 and 0.98.
Universal Goniometer
Time frame: upto 4 weeks
An instrument called a goniometer was used to measure a joint's range of motion. Physical therapists typically use a goniometer to measure a range of motion. At the initial evaluation, the therapist can determine the possible range of motion using a goniometer. The reliability is (r = .58). Neck ROM will be measured in this study using a Universal Goniometer.
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 15 Oct 2024.
- BackgroundSaleem I, Zahoor IA, Rana AA, Sarfraz S, Ibrahim M, Ghaffar N. Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects on Pain, Range of Motion and Neck Disability in Patients with Chronic Neck Pain: Comparison of Sustained Natural Apophyseal Glide and Natural Apophyseal Glide Effects. Pakistan Journal of Health Sciences. 2022:154-8.
- Background: PubMed 36359533Tatsios PI, Grammatopoulou E, Dimitriadis Z, Koumantakis GA. The Effectiveness of Manual Therapy in the Cervical Spine and Diaphragm, in Combination with Breathing Reeducation Exercises, in Patients with Non-Specific Chronic Neck Pain: Protocol for Development of Outcome Measures and a Randomized Controlled Trial. Diagnostics (Basel). 2022 Nov 4;12(11):2690. doi: 10.3390/diagnostics12112690.
- BackgroundPal A, Misra A. EFFECTIVENESS OF SNAG MOBILIZATION ON COMPUTER PROFES-SIONALS WITH MECHANICAL NECK PAIN AND MOBILITY DEFICIT. Int J Physiother Res. 2019;7(2):3022-27.
- Background: PubMed 41316631Haghighat F, Moradi R, Rezaie M, Yarahmadi N, Ghaffarnejad F. Added value of diaphragm myofascial release on forward head posture and chest expansion in women with symptomatic forward head posture: A randomized controlled trial. J Bodyw Mov Ther. 2025 Dec;45:645-651. doi: 10.1016/j.jbmt.2025.07.015. Epub 2025 Aug 8.
- Background: PubMed 33992285Simoni G, Bozzolan M, Bonnini S, Grassi A, Zucchini A, Mazzanti C, Oliva D, Caterino F, Gallo A, Da Roit M. Effectiveness of standard cervical physiotherapy plus diaphragm manual therapy on pain in patients with chronic neck pain: A randomized controlled trial. J Bodyw Mov Ther. 2021 Apr;26:481-491. doi: 10.1016/j.jbmt.2020.12.032. Epub 2021 Feb 16.
- Background: PubMed 33896809Jabbar KM, Gandomi F. The comparison of two corrective exercise approaches for hyperkyphosis and forward head posture: A quasi-experimental study. J Back Musculoskelet Rehabil. 2021;34(4):677-687. doi: 10.3233/BMR-200160.
- Background: PubMed 32723399Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
- Individual participant dataSharing planned: No
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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.
Anam Akram, MSPT* principal investigator
Riphah International University,Lahore
samrood Akram study director
Riphah International 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 Baseline treatment in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 11 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 15 Oct 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 Pakistan. 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?
Numeric Pain Rating Scale (NPRS) (time frame: upto 4 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?
On the ClinicalTrials.gov record for NCT06460532, which also lists 7 linked publications.
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 15 Oct 2024.