Neck PainNCT05272111
Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain
A study testing DBM fasciatherapy+ conventional physical therapy and fascial manipulation+ conventional physical therapy in people with Neck Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain. A sample of 52 patients will be taken and divided into two groups each with 26 patients. 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?
- DBM fasciatherapy+ conventional physical therapy and fascial manipulation+ conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Feb 2022to 30 Aug 2022
- 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
- Both genders
- Age 18-40 years
- Chronicity of pain - 6 months minimum
Who cannot join
- Post-op patient
- Any bony, soft tissue or systemic disease
- Pregnant females
- Radiculopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fasciatherapy Versus Facial Manipulation on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
This study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain. A sample of 52 patients will be taken and divided into two groups each with 26 patients. Group A will receive DBM fasciatherapy along with conventional physical therapy while group B will receive fascial manipulation along with the conventional physical therapy protocol. The conventional physical therapy protocol will include hot pack, neck isometrics and stretches. The session will be around 45 to 60 min on each patient with three session per week on alternate days. A total of three-week treatment regime will be given to the patients and assessment of patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometry and NDI (neck disability index) will be done at the baseline, after the completion of treatment at three weeks and after 6 weeks to observe the long-term effects. The data will be analyzed using SPSS.
Read the detailed description
Chronic neck pain is one of the most common musculoskeletal disorder among general population. Like muscular spasm of neck that can cause neck pain, fascial adhesions are also the common cause of neck pain. Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts and also resist tissue tensile load. Fascial injury and adhesions are common and can lead to pain, restricted motion and swelling. The treatment of the fascial injury is necessary to relieve those symptoms. There are many treatments for the chronic neck pain and this study focuses on two new treatment techniques for the fascial pain. The first is the Dannis Bois method fasciatherpy which is a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues. The other treatment technique is the fascial manipulation method that involves the treatment which is directed to specific fascial adhesions. The current study is novel in a way that there is limited literature about DBM fasciatherapy versus fascial manipulation on chronic neck pain. Both methods were employed to see if they improve ranges along with accompanying pain and disability.
- Conditions
- Neck Pain
- Being tested
- DBM fasciatherapy+ conventional physical therapy, fascial manipulation+ conventional physical therapy
- Keywords
- Neck Pain, Fascia Therapy, Facial Manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBM fasciatherapy+ conventional physical therapyOther
DBM fasciatherapy (3 sessions per day). It soft, deep and non-manipulative form of treatment that involves the application of gentle pressure while stretching the body's connective tissue. A specialized form of touch, somatic sense, and specific body movement protocols are the three steps involved in the fasciatherapy. + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation). A total of 45 min session three times a week on alternate days for three weeks
fascial manipulation+ conventional physical therapyOther
Fascial manipulation (3 sessions per day). This technique involves the identification of specific, localized areas of the fascia with limited movements. Once it is identified, then a specific point on the fascia is targeted and through the appropriate manipulation of this precise part of the fascia, movement can be restored. + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation). A total of 45 min session three times a week on alternate days for three weeks
| Study group | Role | What they receive |
|---|---|---|
| Fascia Therapy | Experimental | Group A will receive Fascia therapy Receives: Other: DBM fasciatherapy+ conventional physical therapy |
| Facial Manipulation | Experimental | Group B will receive Facial manipulation Receives: Other: fascial manipulation+ conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. NPRS (numeric pain rating scale)
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
Measured: 6th Week
2. Goniometer
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it.
Measured: 6th Week
NDI
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
Measured: 6th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start20 Feb 2022
- Primary completion30 Jul 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Shakil ur Rehman, Study director, Riphah International UniversitySyeda Aiman Batool, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272111
- Sponsor's protocol ID
- REC/RCRS/22/0102 Aiman
- Status last verified
- Oct 2022
- First submitted
- 20 Feb 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.
PubMed 20466711Quere N, Noel E, Lieutaud A, d'Alessio P. Fasciatherapy combined with pulsology touch induces changes in blood turbulence potentially beneficial for vascular endothelium. J Bodyw Mov Ther. 2009 Jul;13(3):239-45. doi: 10.1016/j.jbmt.2008.06.012. Epub 2008 Aug 12.
PubMed 19524848Branchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation(R) for chronic aspecific low back pain: a single blinded randomized controlled trial. F1000Res. 2015 Nov 3;4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015.
PubMed 26834998Rodriguez-Huguet M, Rodriguez-Almagro D, Rodriguez-Huguet P, Martin-Valero R, Lomas-Vega R. Treatment of Neck Pain With Myofascial Therapies: A Single Blind Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Feb;43(2):160-170. doi: 10.1016/j.jmpt.2019.12.001. Epub 2020 Apr 18.
PubMed 32317109Mawdsley RH, Moran KA, Conniff LA. Reliability of two commonly used pain scales with elderly patients. Journal of Geriatric Physical Therapy. 2002;25(3):16.
Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
PubMed 29856244Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.
PubMed 19329049Courraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
PubMed 21589701Batool SA, Shakil-Ul-Rehman S, Tariq Z, Ikram M. Effects of fasciatherapy versus fascial manipulation on pain, range of motion and function in patients with chronic neck pain. BMC Musculoskelet Disord. 2023 Oct 5;24(1):789. doi: 10.1186/s12891-023-06769-0.
PubMed 37798756
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fasciatherapy Versus Facial Manipulation on Pain, Range of Motion and Function in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05272111
- Acronym / sponsor ID
- REC/RCRS/22/0102 Aiman
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Fascia Therapy, Facial Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 9 Mar 2022 (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.
This study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain. A sample of 52 patients will be taken and divided into two groups each with 26 patients. Group A will receive DBM fasciatherapy along with conventional physical therapy while group B will receive fascial manipulation along with the conventional physical therapy protocol. The conventional physical therapy protocol will include hot pack, neck isometrics and stretches. The session will be around 45 to 60 min on each patient with three session per week on alternate days. A total of three-week treatment regime will be given to the patients and assessment of patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometry and NDI (neck disability index) will be done at the baseline, after the completion of treatment at three weeks and after 6 weeks to observe the long-term effects. The data will be analyzed using SPSS.
Detailed description
Chronic neck pain is one of the most common musculoskeletal disorder among general population. Like muscular spasm of neck that can cause neck pain, fascial adhesions are also the common cause of neck pain. Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts and also resist tissue tensile load. Fascial injury and adhesions are common and can lead to pain, restricted motion and swelling. The treatment of the fascial injury is necessary to relieve those symptoms. There are many treatments for the chronic neck pain and this study focuses on two new treatment techniques for the fascial pain. The first is the Dannis Bois method fasciatherpy which is a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues. The other treatment technique is the fascial manipulation method that involves the treatment which is directed to specific fascial adhesions. The current study is novel in a way that there is limited literature about DBM fasciatherapy versus fascial manipulation on chronic neck pain. Both methods were employed to see if they improve ranges along with accompanying pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Therapy | Experimental | Other: DBM fasciatherapy+ conventional physical therapyGroup A will receive Fascia therapy |
| Facial Manipulation | Experimental | Other: fascial manipulation+ conventional physical therapyGroup B will receive Facial manipulation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders
- Age 18-40 years
- Chronicity of pain - 6 months minimum
Key exclusion criteria (4 listed)
- Post-op patient
- Any bony, soft tissue or systemic disease
- Pregnant females
- Radiculopathy
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 |
|---|---|---|
| DBM fasciatherapy+ conventional physical therapyDBM fasciatherapy (3 sessions per day). It soft, deep and non-manipulative form of treatment that involves the application of gentle pressure while stretching the body's connective tissue. A specialized form of touch, somatic sense, and specific body movement protocols are the three steps involved in the fasciatherapy. + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation). A total of 45 min session three times a week on alternate days for three weeks | Other | Fascia Therapy |
| fascial manipulation+ conventional physical therapyFascial manipulation (3 sessions per day). This technique involves the identification of specific, localized areas of the fascia with limited movements. Once it is identified, then a specific point on the fascia is targeted and through the appropriate manipulation of this precise part of the fascia, movement can be restored. + hot pack (10 min) + neck isometrics (neck flexion, extension, side bending) + neck stretches (neck flexors, extensors, side benders and rotation). A total of 45 min session three times a week on alternate days for three weeks | Other | Facial Manipulation |
Primary outcome
1. NPRS (numeric pain rating scale)
Time frame: 6th Week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
2. Goniometer
Time frame: 6th Week
The science of measuring the joint ranges in each plane of the joint is called goniometry. Goniometer is a device that measures an angle or permits the rotation of an object to a definite position. Neck flexion, extension, side bending and rotation will be assessed through it.
NDI
Time frame: 6th Week
The NDI has become a standard instrument for measuring self-rated disability due to neck pain. Each of the 10 items scores from 0 to 5. The maximum score is 50.
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 19 Oct 2022.
- Background: PubMed 20466711McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.
- Background: PubMed 19524848Quere N, Noel E, Lieutaud A, d'Alessio P. Fasciatherapy combined with pulsology touch induces changes in blood turbulence potentially beneficial for vascular endothelium. J Bodyw Mov Ther. 2009 Jul;13(3):239-45. doi: 10.1016/j.jbmt.2008.06.012. Epub 2008 Aug 12.
- Background: PubMed 26834998Branchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation(R) for chronic aspecific low back pain: a single blinded randomized controlled trial. F1000Res. 2015 Nov 3;4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015.
- Background: PubMed 32317109Rodriguez-Huguet M, Rodriguez-Almagro D, Rodriguez-Huguet P, Martin-Valero R, Lomas-Vega R. Treatment of Neck Pain With Myofascial Therapies: A Single Blind Randomized Controlled Trial. J Manipulative Physiol Ther. 2020 Feb;43(2):160-170. doi: 10.1016/j.jmpt.2019.12.001. Epub 2020 Apr 18.
- BackgroundMawdsley RH, Moran KA, Conniff LA. Reliability of two commonly used pain scales with elderly patients. Journal of Geriatric Physical Therapy. 2002;25(3):16.
- Background: PubMed 29856244Young IA PT, DSc, Dunning J PT, DPT, Butts R PT, PhD, Mourad F PT, DPT, Cleland JA PT, PhD. Reliability, construct validity, and responsiveness of the neck disability index and numeric pain rating scale in patients with mechanical neck pain without upper extremity symptoms. Physiother Theory Pract. 2019 Dec;35(12):1328-1335. doi: 10.1080/09593985.2018.1471763. Epub 2018 Jun 1.
- Background: PubMed 19329049Day JA, Stecco C, Stecco A. Application of Fascial Manipulation technique in chronic shoulder pain--anatomical basis and clinical implications. J Bodyw Mov Ther. 2009 Apr;13(2):128-35. doi: 10.1016/j.jbmt.2008.04.044. Epub 2008 Jun 24.
- BackgroundCourraud C, Bertrand I, Dupuis C. Assessment of the effects of DBM fasciatherapy on fascial system with elastography.
- Background: PubMed 21589701Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
- Derived from this study: PubMed 37798756Batool SA, Shakil-Ul-Rehman S, Tariq Z, Ikram M. Effects of fasciatherapy versus fascial manipulation on pain, range of motion and function in patients with chronic neck pain. BMC Musculoskelet Disord. 2023 Oct 5;24(1):789. doi: 10.1186/s12891-023-06769-0.
- 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.
Syed Shakil ur Rehman study director
Riphah International University
Syeda Aiman Batool principal investigator
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 DBM fasciatherapy+ conventional physical therapy and fascial manipulation+ conventional physical therapy 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 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 19 Oct 2022. 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?
1. NPRS (numeric pain rating scale) (time frame: 6th Week). 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 NCT05272111, which also lists 10 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 19 Oct 2022.