Neck Pain ChronicNCT06803264
Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome
A study testing Activity Oriented therapy (N.A.P.) and Traditional therapy in people with Neck Pain Chronic and Depression Disorders, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
Title: Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome Procedures: You will be asked to complete a form containing questions characterizing the study group and several questionnaires before starting treatment, such as: NDI, CESD-R, STAI and the NRS scale. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Neck Pain Chronic, Depression Disorders, Forward Head Posture
- What is being tested?
- Activity Oriented therapy (N.A.P.) and Traditional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePoland
- Study dates
- 18 Mar 2021to 8 Apr 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- qualifying: non-traumatic, disc-like, chronic (symptoms lasting more than 3 months) cervical pain of mechanical origin, localized in the cervical region with the possibility of radiation to the upper edge of the scapula and head (without root symptoms and neurological disorders), classified as syndrome No. 1 according to the Quebec Task Force (QTF) Classification, and a condition not requiring surgery.
Who cannot join
- comorbid advanced neurological, rheumatic, urological, psychiatric diseases, and unsystematic participation in in therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Title: Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome
Procedures: You will be asked to complete a form containing questions characterizing the study group and several questionnaires before starting treatment, such as: NDI, CESD-R, STAI and the NRS scale. A photo of the head and shoulder area will also be taken in a front and side standing position. After completing the two-week treatment, you will be asked again to complete questionnaires and pose for photos. You will be informed about a follow-up visit 3 months after the end of therapy, during which you will be asked for the last time to complete questionnaires and pose for a photo.
Read more
Benefits: There are no direct benefits to you other than participating in a therapy more commonly used for cervical pain syndromes and the opportunity to discuss your experience with neck pain with a specialist. The information we obtain will help scientists better understand the problem of treating neck pain.
Risk: There are no physical risks to you while conducting this research. All information obtained from you will be anonymous. Your name and image will not be used in this study or reports.
Confidentiality: All research records will be confidential and appropriately secured. Records will only be published with your consent or by court order or as required by law. Any publication resulting from this research will not use identifying information, such as your name or likeness.
Freedom to opt out: Participation in the study is completely voluntary and free of charge. You may withdraw from this study at any time without any consequences.
Read the detailed description
The purpose of the study was to evaluate the effectiveness of the Activity Oriented Therapy (N.A.P. therapy) and traditional therapy during disc-related neck pain in terms of pain intensity, disability, Forward Head Posture (FHP), anxiety as a condition and level of depression. Patients were qualified based on a medical examination. Respondents were randomly divided into two groups.
The therapies were performed by experienced physiotherapists in cooperation with a psychologist. Treatment in both groups included 10 therapy sessions held daily from Monday to Friday over a two-week period.
- Being tested
- Activity Oriented therapy (N.A.P.), Traditional therapy
- Keywords
- N.A.P. therapy, breathing exercises, neuroplasticity, forward head posture, chronic neck pain, psychosomatic diseases.
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity Oriented therapy (N.A.P.)Other
The following six exercises were used, each of which was performed 10 times. Their progression was introduced by changing positions, individually adjusted to the patient's capabilities.
- Eccentric infrahyoid muscle work during breathing activity and phonation of the "l"sound.
- Reciprocal innervation of suboccipital muscles in gaze activity.
- Stimulation of the diaphragm in the activity of breathing and phonation.
- Repeated eccentric activity of the sternocleidomastoid (SCM) muscles during body transfer activity.
- Repeated eccentric activity of scalene muscles in blanket pulling activity.
- Eccentric work of suboccipital muscles in the activity of biting a snack.
Traditional therapyOther
Traditional therapy included:
- Isometric work of the neck muscles.
- Self-assisted active exercises for the shoulder girdle muscles.
- Active exercises in relief for the muscles of the shoulder girdle performed in the sitting position in the transverse plane.
- TENS current treatment performed in the cervical spine and shoulder girdle in the forward lying position.
- The local cryotherapy treatment with carbon dioxide.
| Study group | Role | What they receive |
|---|---|---|
| N.A.P. therapy group | Experimental | Activity Oriented therapy (N.A.P.) is based on the assumption that motor activity affects the plasticity of the brain and it stimulates a positive change in its cortical representation. The therapist use motor teaching techniques, postural control exercises and improving respiratory functions. Breathing exercises are used to reduce nervous system stimulation, activating the parasympathetic system and relaxing the body and mind. Additionally, diaphragm exercises affect the stabilization of the spine muscles. Receives: Other: Activity Oriented therapy (N.A.P.) |
| Traditional therapy group | Active comparator | In Poland, traditional treatment of neck pain includes physical treatments (e.g. cryotherapy or TENS) and exercises to strengthen and improve the range of muscles in the shoulder girdle and neck. Research shows that these interventions provide good benefits in the treatment of neck pain immediately after therapy, but there is often a lack of information about how this change is maintained over time. Considering the psychological aspect of chronic pain, such actions may not be sufficient to effectively cure the problem. Receives: Other: Traditional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NRS)
The Numerical Rating Scale (NRS), which contains 11 levels of pain intensity, where 0 means no pain and 10 means maximum pain
Measured: Before therapy, after two weeks of treatment and after 3 months of follow-up
The Neck Disability Index (NDI)
The Neck Disability Index (NDI) questionnaire, which examines the level of disability from NP. A patient can score between 0 and 50 points. A score between 1-4 points indicates no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and above 35 points total disability.
Measured: Before therapy, after two weeks of treatment and after 3 months of follow-up
The photographic method to assess Forward Head Posture (FHP)
The photographic method to assess FHP. Based on photographs of the shoulder area and head taken in the forward and lateral standing positions, two angles were measured using the computer program GIMP (version 2.10.34). The camera was placed on a tripod at a distance of 150 cm from the patient. Cranio Vertebral Angle (CVA) was measured in the sagittal plane, while Frontal Head Tilt angle (FHT) was measured in the frontal plane. A higher score for CVA and a lower score for FHT indicate improvement in FHP. The reliability of the described procedure is rated as high. In the author's study, images were taken with a SONY DSC-W810B camera.
Measured: Before therapy, after two weeks of treatment and after 3 months of follow-up
The State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI), which examines the level of anxiety understood as a transient and situationally conditioned state of the individual and anxiety as a relatively stable personality trait. The STAI consists of two subscales, but only the scale for measuring anxiety-state (X-1) was used in this study. Each subscale can be scored from 20 to 80. High values indicate higher levels of anxiety.
Measured: Before therapy, after two weeks of treatment and after 3 months of follow-up
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R). This is a self-report scale that examines levels of depression. It consists of 20 statements relating to mood and behavior observed over the past two weeks. The lowest score is 0 and the highest score is 80. The higher the scores, the higher the level of depression.
Measured: Before therapy, after two weeks of treatment and after 3 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start18 Mar 2021
- Primary completion20 Dec 2021
- Study completion8 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neck Pain ChronicStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803264
- Sponsor's protocol ID
- 40/KBL/OIL/2020
- Status last verified
- Jun 2023
- First submitted
- 27 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The article includes data such as age, gender and duration of symptoms.
Publications
Szczygiel E, Fudacz N, Golec J, Golec E. The impact of the position of the head on the functioning of the human body: a systematic review. Int J Occup Med Environ Health. 2020 Sep 17;33(5):559-568. doi: 10.13075/ijomeh.1896.01585. Epub 2020 Jul 23.
PubMed 32713947Jerath R, Beveridge C. Respiratory Rhythm, Autonomic Modulation, and the Spectrum of Emotions: The Future of Emotion Recognition and Modulation. Front Psychol. 2020 Aug 14;11:1980. doi: 10.3389/fpsyg.2020.01980. eCollection 2020.
PubMed 32922338Maric V, Ramanathan D, Mishra J. Respiratory regulation & interactions with neuro-cognitive circuitry. Neurosci Biobehav Rev. 2020 May;112:95-106. doi: 10.1016/j.neubiorev.2020.02.001. Epub 2020 Feb 3.
PubMed 32027875Nitayarak H, Charntaraviroj P. Effects of scapular stabilization exercises on posture and muscle imbalances in women with upper crossed syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(6):1031-1040. doi: 10.3233/BMR-200088.
PubMed 34151819Schuch FB, Vancampfort D, Richards J, Rosenbaum S, Ward PB, Stubbs B. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. J Psychiatr Res. 2016 Jun;77:42-51. doi: 10.1016/j.jpsychires.2016.02.023. Epub 2016 Mar 4.
PubMed 26978184Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
PubMed 28807894Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
PubMed 25659245Elman I, Borsook D. Common Brain Mechanisms of Chronic Pain and Addiction. Neuron. 2016 Jan 6;89(1):11-36. doi: 10.1016/j.neuron.2015.11.027.
PubMed 26748087
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome
- ClinicalTrials.gov ID
- NCT06803264
- Acronym / sponsor ID
- 40/KBL/OIL/2020
- Keywords
- N.A.P. therapy, breathing exercises, neuroplasticity, forward head posture, chronic neck pain, psychosomatic diseases.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 31 Jan 2025 (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.
Title: Effectiveness of Activity Oriented Therapy and Traditional Therapy in Cervical Discopathic Pain Syndrome
Procedures: You will be asked to complete a form containing questions characterizing the study group and several questionnaires before starting treatment, such as: NDI, CESD-R, STAI and the NRS scale. A photo of the head and shoulder area will also be taken in a front and side standing position. After completing the two-week treatment, you will be asked again to complete questionnaires and pose for photos. You will be informed about a follow-up visit 3 months after the end of therapy, during which you will be asked for the last time to complete questionnaires and pose for a photo.
Benefits: There are no direct benefits to you other than participating in a therapy more commonly used for cervical pain syndromes and the opportunity to discuss your experience with neck pain with a specialist. The information we obtain will help scientists better understand the problem of treating neck pain.
Risk: There are no physical risks to you while conducting this research. All information obtained from you will be anonymous. Your name and image will not be used in this study or reports.
Confidentiality: All research records will be confidential and appropriately secured. Records will only be published with your consent or by court order or as required by law. Any publication resulting from this research will not use identifying information, such as your name or likeness.
Freedom to opt out: Participation in the study is completely voluntary and free of charge. You may withdraw from this study at any time without any consequences.
Detailed description
The purpose of the study was to evaluate the effectiveness of the Activity Oriented Therapy (N.A.P. therapy) and traditional therapy during disc-related neck pain in terms of pain intensity, disability, Forward Head Posture (FHP), anxiety as a condition and level of depression. Patients were qualified based on a medical examination. Respondents were randomly divided into two groups.
The therapies were performed by experienced physiotherapists in cooperation with a psychologist. Treatment in both groups included 10 therapy sessions held daily from Monday to Friday over a two-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N.A.P. therapy group | Experimental | Other: Activity Oriented therapy (N.A.P.)Activity Oriented therapy (N.A.P.) is based on the assumption that motor activity affects the plasticity of the brain and it stimulates a positive change in its cortical representation. The therapist use motor teaching techniques, postural control exercises and improving respiratory functions. Breathing exercises are used to reduce nervous system stimulation, activating the parasympathetic system and relaxing the body and mind. Additionally, diaphragm exercises affect the stabilization of the spine muscles. |
| Traditional therapy group | Active comparator | Other: Traditional therapyIn Poland, traditional treatment of neck pain includes physical treatments (e.g. cryotherapy or TENS) and exercises to strengthen and improve the range of muscles in the shoulder girdle and neck. Research shows that these interventions provide good benefits in the treatment of neck pain immediately after therapy, but there is often a lack of information about how this change is maintained over time. Considering the psychological aspect of chronic pain, such actions may not be sufficient to effectively cure the problem. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- qualifying: non-traumatic, disc-like, chronic (symptoms lasting more than 3 months) cervical pain of mechanical origin, localized in the cervical region with the possibility of radiation to the upper edge of the scapula and head (without root symptoms and neurological disorders), classified as syndrome No. 1 according to the Quebec Task Force (QTF) Classification, and a condition not requiring surgery.
Key exclusion criteria (1 listed)
- comorbid advanced neurological, rheumatic, urological, psychiatric diseases, and unsystematic participation in in therapy.
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 |
|---|---|---|
| Activity Oriented therapy (N.A.P.)The following six exercises were used, each of which was performed 10 times. Their progression was introduced by changing positions, individually adjusted to the patient's capabilities. 1. Eccentric infrahyoid muscle work during breathing activity and phonation of the "l"sound. 2. Reciprocal innervation of suboccipital muscles in gaze activity. 3. Stimulation of the diaphragm in the activity of breathing and phonation. 4. Repeated eccentric activity of the sternocleidomastoid (SCM) muscles during body transfer activity. 5. Repeated eccentric activity of scalene muscles in blanket pulling activity. 6. Eccentric work of suboccipital muscles in the activity of biting a snack. | Other | N.A.P. therapy group |
| Traditional therapyTraditional therapy included: 1. Isometric work of the neck muscles. 2. Self-assisted active exercises for the shoulder girdle muscles. 3. Active exercises in relief for the muscles of the shoulder girdle performed in the sitting position in the transverse plane. 4. TENS current treatment performed in the cervical spine and shoulder girdle in the forward lying position. 5. The local cryotherapy treatment with carbon dioxide. | Other | Traditional therapy group |
Primary outcome
The Numerical Rating Scale (NRS)
Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up
The Numerical Rating Scale (NRS), which contains 11 levels of pain intensity, where 0 means no pain and 10 means maximum pain
The Neck Disability Index (NDI)
Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up
The Neck Disability Index (NDI) questionnaire, which examines the level of disability from NP. A patient can score between 0 and 50 points. A score between 1-4 points indicates no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and above 35 points total disability.
The photographic method to assess Forward Head Posture (FHP)
Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up
The photographic method to assess FHP. Based on photographs of the shoulder area and head taken in the forward and lateral standing positions, two angles were measured using the computer program GIMP (version 2.10.34). The camera was placed on a tripod at a distance of 150 cm from the patient. Cranio Vertebral Angle (CVA) was measured in the sagittal plane, while Frontal Head Tilt angle (FHT) was measured in the frontal plane. A higher score for CVA and a lower score for FHT indicate improvement in FHP. The reliability of the described procedure is rated as high. In the author's study, images were taken with a SONY DSC-W810B camera.
The State-Trait Anxiety Inventory (STAI)
Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up
The State-Trait Anxiety Inventory (STAI), which examines the level of anxiety understood as a transient and situationally conditioned state of the individual and anxiety as a relatively stable personality trait. The STAI consists of two subscales, but only the scale for measuring anxiety-state (X-1) was used in this study. Each subscale can be scored from 20 to 80. High values indicate higher levels of anxiety.
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)
Time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up
The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R). This is a self-report scale that examines levels of depression. It consists of 20 statements relating to mood and behavior observed over the past two weeks. The lowest score is 0 and the highest score is 80. The higher the scores, the higher the level of depression.
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 31 Jan 2025.
- Background: PubMed 32713947Szczygiel E, Fudacz N, Golec J, Golec E. The impact of the position of the head on the functioning of the human body: a systematic review. Int J Occup Med Environ Health. 2020 Sep 17;33(5):559-568. doi: 10.13075/ijomeh.1896.01585. Epub 2020 Jul 23.
- Background: PubMed 32922338Jerath R, Beveridge C. Respiratory Rhythm, Autonomic Modulation, and the Spectrum of Emotions: The Future of Emotion Recognition and Modulation. Front Psychol. 2020 Aug 14;11:1980. doi: 10.3389/fpsyg.2020.01980. eCollection 2020.
- Background: PubMed 32027875Maric V, Ramanathan D, Mishra J. Respiratory regulation & interactions with neuro-cognitive circuitry. Neurosci Biobehav Rev. 2020 May;112:95-106. doi: 10.1016/j.neubiorev.2020.02.001. Epub 2020 Feb 3.
- Background: PubMed 34151819Nitayarak H, Charntaraviroj P. Effects of scapular stabilization exercises on posture and muscle imbalances in women with upper crossed syndrome: A randomized controlled trial. J Back Musculoskelet Rehabil. 2021;34(6):1031-1040. doi: 10.3233/BMR-200088.
- Background: PubMed 26978184Schuch FB, Vancampfort D, Richards J, Rosenbaum S, Ward PB, Stubbs B. Exercise as a treatment for depression: A meta-analysis adjusting for publication bias. J Psychiatr Res. 2016 Jun;77:42-51. doi: 10.1016/j.jpsychires.2016.02.023. Epub 2016 Mar 4.
- Background: PubMed 28807894Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
- Background: PubMed 25659245Cohen SP. Epidemiology, diagnosis, and treatment of neck pain. Mayo Clin Proc. 2015 Feb;90(2):284-99. doi: 10.1016/j.mayocp.2014.09.008.
- Background: PubMed 26748087Elman I, Borsook D. Common Brain Mechanisms of Chronic Pain and Addiction. Neuron. 2016 Jan 6;89(1):11-36. doi: 10.1016/j.neuron.2015.11.027.
- Individual participant dataSharing planned: Undecided. The article includes data such as age, gender and duration of symptoms.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity Oriented therapy (N.A.P.) and Traditional therapy in people with Neck Pain Chronic and Depression Disorders, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 1 inclusion and 1 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 31 Jan 2025. 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 Poland. 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?
The Numerical Rating Scale (NRS) (time frame: Before therapy, after two weeks of treatment and after 3 months of follow-up). The study lists 5 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 NCT06803264, which also lists 8 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 31 Jan 2025.