Non-specific Chronic Neck PainNCT04695730
Comparison Between Two Physical Therapy Treatments in Patients With Nonspecific Chronic Neck Pain
A study testing Active physical therapy (including both pain education and home exercises) and Active physical therapy plus manual therapy in people with Non-specific Chronic Neck Pain, run by University of Bologna at 1 site in Italy.
Trial summary
Introduction: Non-specific chronic neck pain is a very prevalent condition in the population ranging from 45% to 54%. Several conservative treatments have been shown to be effective and are currently used in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-specific Chronic Neck Pain
- What is being tested?
- Active physical therapy (including both pain education and home exercises) and Active physical therapy plus manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 9 Feb 2021to 31 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects aged between 18 and 80 years with non-specific neck pain lasting for more than 3 months.
- Informed consent
Who cannot join
- Subjects with acute or subacute neck pain;
- Subjects with specific etiology for neck pain (e.g. trauma, herniated disc, vertebral deformities, fractures);
- Subjects with central or peripheral neurological signs;
- Individuals with systemic diseases, neuromuscular diseases, rheumatic diseases, cognitive deficit, tumors;
- Subjects who underwent surgery within 6 months preceding enrollment;
- Subjects who underwent physical therapy treatment within 6 months preceding enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: Non-specific chronic neck pain is a very prevalent condition in the population ranging from 45% to 54%. Several conservative treatments have been shown to be effective and are currently used in clinical practice. However, among the physical therapy ones, no study evaluated the effectiveness of Pompage techniques in addition to an active treatment.
This protocol describes a controlled, randomized trial that aims to assess the effectiveness of two physical therapy treatments in patients with chronic non-specific neck pain.
Read more
Methods: Seventy subjects with chronic nonspecific neck pain from 18 to 80 years will be recruited according to the inclusion criteria.
Afterwards they will be randomized to one of the 2 groups: group 1 (G1) will undergo an active intervention and group 2 (G2) will receive the same active intervention plus manual technique. Active intervention, according to the current guidelines on non-specific neck pain, will be a treatment including both pain education and home exercises; manual technique will be the so-called "Pompage" technique.
A booster session will be planned for both groups after 4 weeks from the beginning of the trial, to reinforce the patients adherence to the self-treatment.
The patients will be evaluated before the treatments (baseline, T0), after 8 weeks from the beginning of the treatments (T1), and 6 months after the end of the treatments (T2).
The primary outcome will be pain perception, which will be assessed using a Visual Analogue Scale (VAS).
The secondary outcomes will be: kinesiophobia (measured with the Tampa Scale of Kinesiophobia - TSK), physical function (measured with the Neck Disability Index - NDI), active cervical range of motion - ROM (measured with the "CROM Deluxe" device), patient satisfaction for treatment (measured with the Physical Therapy Satisfaction Questionnaire - PTPSQI(15)), and subjective perception of improvement (measured with the Global Perceived Effect - GPE).
Adverse effects will be registered. Discussion: Considering that there is no consensus on the use of Pompage techniques in addition to an active treatment in individuals with nonspecific chronic neck pain, our protocol will be the basis for the use of these techniques by health professionals and for new studies to be performed.
Read the detailed description
PROTOCOL OF INTERVENTIONS
The intervention of group 1 (G1) is based on education and selective strengthening exercises for cervical muscles, and involves a protocol that must be performed by the patient for 8 weeks. Halfway through the course (at the end of the fourth week) the physical therapist will carry out a reinforcement session, to monitor the clinical situation, motivate the patient and resolve any doubts (booster session).
In group 2 (G2) the "Pompage" treatment will be added to this intervention.
HOME EXERCISES: CONTENTS
In the first session supervised by a physical therapist, lasting 30 minutes, the patient will be taught all the home exercises that he/she will have to perform and will be given:
- a hard copy with the exercise reminder;
- a diary for recording the daily execution of the exercises. The patients will be instructed to perform the exercises on a daily basis, without feeling pain. These exercises focus on strengthening the deep muscles of the neck; cranio-cervical flexor muscles and cervical extensors.
PAIN EDUCATION: CONTENTS
The educational intervention will take place verbally in a 30-minute session (explanation by the physical therapist), and will be supported by images, diagrams and summaries.
During this intervention, the patient will be provided with information on chronic non-specific cervical pain and on "pain neuroscience education". The education session will focus on explaining the mechanisms through which the body perceives and interprets pain. The aim is to make the patient aware that experiencing pain does not necessarily mean that there is a damage on a part of the body. During this educational session, the physical therapist will try to encourage the patient to ask questions.
At the end of this session, the patient will be given an information booklet on pain, with references to the themes just explored. This booklet provides further examples and ideas for elaborating and fixing the concepts learned during the session supervised by the physical therapist.
MANUAL THERAPY: CONTENTS
The treatment of group 2 (G2) combines the previous treatments with eight 30-minutes sessions of passive manual therapy, using the "Pompage" technique, carried out according to the indications shown in the monograph: "Zanella F, Vanti C. Pompage technique. The myofascial release. Piccin, Padua, 2015." The "Pompage" technique includes gradual and progressive soft tissue and fascia mobilization procedures, with the aim to obtain the myofascial release. This procedure is performed without provoking pain or forcing movements beyond the passive physiological range of motion. It consists of an alternation of rhythmic pressure and decompression, located at cervical joints and muscles (e.g. Trapezius Superior, Levator scapulae, Scalenus, Sterno-Cleido-Occipito-Mastoideus, etc.).
- Conditions
- Non-specific Chronic Neck Pain
- Being tested
- Active physical therapy (including both pain education and home exercises), Active physical therapy plus manual therapy
- Keywords
- neck pain, chronic neck pain, musculoskeletal disorder
- Medical subject headings
- Neck Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active physical therapy (including both pain education and home exercises)Other
One session (60 minutes). In this session, a physical therapist will explain and demonstrate the exercises to perform individually at home. Exercises will be performed daily. In addition, an education session will be provided, concerning pain mechanisms and management. To support patients during the treatment, a booklet will be created.
One booster session (30minutes) will be planned after 4 weeks. Patients will follow the active treatment for 8 weeks.
Active physical therapy plus manual therapyOther
Participants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Active physical therapy | Active comparator | Active intervention (including both pain education and home exercises). A 60-minutes education session will be provided, concerning pain mechanisms and management and a demonstration of the exercises to perform individually at home. Home exercises will be performed daily. To support patients during the treatment, a booklet will be created. One 30-minutes booster session will be planned after 4 weeks. Patients will follow this active intervention for 8 weeks. Receives: Other: Active physical therapy (including both pain education and home exercises) |
| Active physical therapy plus manual therapy | Experimental | Participants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist. Receives: Other: Active physical therapy plus manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain
Visual Analogue Scale (VAS). VAS is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
Measured: At baseline, 8 weeks, and 6 months.
Secondary outcomes (5)
Changes in neck disability
Italian version of Neck Disability Index (NDI) The test can be interpreted as a raw score, with a maximum score of 50, or as a percentage and includes a total of 10 items.
Score: /50 Transform to percentage score x 100 = %points
Measured: At baseline, 8 weeks, and 6 months.
Changes in Kinesiophobia/Fear of movement
Italian version of Tampa Scale of Kinesiophobia (TSK). Tampa Scale of Kinesiophobia (TSK), provides a measure of fear of movement or injury. The Italian version comprises 13 item divided in two subscales: TSK 1 - Activity Avoidance, and TSK 2-Harm.
- TSK 1 - Activity Avoidance (item 1, 2, 10, 14, 15, 17):___/24
- TSK 2 - Harm (item 3, 5, 6, 7, 9, 11, 13):___/28 The maximum score is 52. An higher score is related to an higher level of fear.
Measured: At baseline, 8 weeks, and 6 months.
Changes in Active Cervical Range of Motion
"CROM Deluxe" device
Measured: At baseline, 8 weeks, and 6 months.
Assessment of the satisfaction for physical therapy
Italian version of Physical Therapy Satisfaction Questionnaire - (PTPSQ-I(15) PTPSQ-I(15) consists of 15 items; for each item the score ranges from 1 to 5. An higher score is related to an higher level of satisfaction.
Measured: At 8 weeks and 6 months.
Assessment of the global perception of improvement on a 7-points Likert Scale
Global Perceived Effect (GPE) questionnaire. The GPE is composed of 1 question on a 7-point Likert-type scale evaluating the subjective self-reported improvement or deterioration after the intervention. GPE is widely used in the physical therapy literature. On the basis of GPE score, patients will be dicotomized into "improved" (a score of 1-3 on the GPE) and "worsened" (a score of 5-7 on the GPE).
Measured: At 8 weeks and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start9 Feb 2021
- Primary completion17 Jun 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, Professor, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695730
- Sponsor's protocol ID
- 679/2020/Sper/AOUBo
- Status last verified
- Sep 2022
- First submitted
- 13 Dec 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Physical Therapy Treatments in Patients With Nonspecific Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04695730
- Acronym / sponsor ID
- 679/2020/Sper/AOUBo
- Conditions
- Non-specific Chronic Neck Pain
- Keywords
- neck pain, chronic neck pain, musculoskeletal disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Non-specific chronic neck pain is a very prevalent condition in the population ranging from 45% to 54%. Several conservative treatments have been shown to be effective and are currently used in clinical practice. However, among the physical therapy ones, no study evaluated the effectiveness of Pompage techniques in addition to an active treatment.
This protocol describes a controlled, randomized trial that aims to assess the effectiveness of two physical therapy treatments in patients with chronic non-specific neck pain.
Methods: Seventy subjects with chronic nonspecific neck pain from 18 to 80 years will be recruited according to the inclusion criteria.
Afterwards they will be randomized to one of the 2 groups: group 1 (G1) will undergo an active intervention and group 2 (G2) will receive the same active intervention plus manual technique. Active intervention, according to the current guidelines on non-specific neck pain, will be a treatment including both pain education and home exercises; manual technique will be the so-called "Pompage" technique.
A booster session will be planned for both groups after 4 weeks from the beginning of the trial, to reinforce the patients adherence to the self-treatment.
The patients will be evaluated before the treatments (baseline, T0), after 8 weeks from the beginning of the treatments (T1), and 6 months after the end of the treatments (T2).
The primary outcome will be pain perception, which will be assessed using a Visual Analogue Scale (VAS).
The secondary outcomes will be: kinesiophobia (measured with the Tampa Scale of Kinesiophobia - TSK), physical function (measured with the Neck Disability Index - NDI), active cervical range of motion - ROM (measured with the "CROM Deluxe" device), patient satisfaction for treatment (measured with the Physical Therapy Satisfaction Questionnaire - PTPSQI(15)), and subjective perception of improvement (measured with the Global Perceived Effect - GPE).
Adverse effects will be registered. Discussion: Considering that there is no consensus on the use of Pompage techniques in addition to an active treatment in individuals with nonspecific chronic neck pain, our protocol will be the basis for the use of these techniques by health professionals and for new studies to be performed.
Detailed description
PROTOCOL OF INTERVENTIONS
The intervention of group 1 (G1) is based on education and selective strengthening exercises for cervical muscles, and involves a protocol that must be performed by the patient for 8 weeks. Halfway through the course (at the end of the fourth week) the physical therapist will carry out a reinforcement session, to monitor the clinical situation, motivate the patient and resolve any doubts (booster session).
In group 2 (G2) the "Pompage" treatment will be added to this intervention.
HOME EXERCISES: CONTENTS
In the first session supervised by a physical therapist, lasting 30 minutes, the patient will be taught all the home exercises that he/she will have to perform and will be given:
- a hard copy with the exercise reminder;
- a diary for recording the daily execution of the exercises. The patients will be instructed to perform the exercises on a daily basis, without feeling pain. These exercises focus on strengthening the deep muscles of the neck; cranio-cervical flexor muscles and cervical extensors.
PAIN EDUCATION: CONTENTS
The educational intervention will take place verbally in a 30-minute session (explanation by the physical therapist), and will be supported by images, diagrams and summaries.
During this intervention, the patient will be provided with information on chronic non-specific cervical pain and on "pain neuroscience education". The education session will focus on explaining the mechanisms through which the body perceives and interprets pain. The aim is to make the patient aware that experiencing pain does not necessarily mean that there is a damage on a part of the body. During this educational session, the physical therapist will try to encourage the patient to ask questions.
At the end of this session, the patient will be given an information booklet on pain, with references to the themes just explored. This booklet provides further examples and ideas for elaborating and fixing the concepts learned during the session supervised by the physical therapist.
MANUAL THERAPY: CONTENTS
The treatment of group 2 (G2) combines the previous treatments with eight 30-minutes sessions of passive manual therapy, using the "Pompage" technique, carried out according to the indications shown in the monograph: "Zanella F, Vanti C. Pompage technique. The myofascial release. Piccin, Padua, 2015." The "Pompage" technique includes gradual and progressive soft tissue and fascia mobilization procedures, with the aim to obtain the myofascial release. This procedure is performed without provoking pain or forcing movements beyond the passive physiological range of motion. It consists of an alternation of rhythmic pressure and decompression, located at cervical joints and muscles (e.g. Trapezius Superior, Levator scapulae, Scalenus, Sterno-Cleido-Occipito-Mastoideus, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active physical therapy | Active comparator | Other: Active physical therapy (including both pain education and home exercises)Active intervention (including both pain education and home exercises). A 60-minutes education session will be provided, concerning pain mechanisms and management and a demonstration of the exercises to perform individually at home. Home exercises will be performed daily. To support patients during the treatment, a booklet will be created. One 30-minutes booster session will be planned after 4 weeks. Patients will follow this active intervention for 8 weeks. |
| Active physical therapy plus manual therapy | Experimental | Other: Active physical therapy plus manual therapyParticipants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female and male subjects aged between 18 and 80 years with non-specific neck pain lasting for more than 3 months.
- Informed consent
Key exclusion criteria (6 listed)
- Subjects with acute or subacute neck pain;
- Subjects with specific etiology for neck pain (e.g. trauma, herniated disc, vertebral deformities, fractures);
- Subjects with central or peripheral neurological signs;
- Individuals with systemic diseases, neuromuscular diseases, rheumatic diseases, cognitive deficit, tumors;
- Subjects who underwent surgery within 6 months preceding enrollment;
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 |
|---|---|---|
| Active physical therapy (including both pain education and home exercises)One session (60 minutes). In this session, a physical therapist will explain and demonstrate the exercises to perform individually at home. Exercises will be performed daily. In addition, an education session will be provided, concerning pain mechanisms and management. To support patients during the treatment, a booklet will be created. One booster session (30minutes) will be planned after 4 weeks. Patients will follow the active treatment for 8 weeks. | Other | Active physical therapy |
| Active physical therapy plus manual therapyParticipants in the Group 2 will receive active intervention plus 8 "Pompage" technique sessions (1 session/week). In these sessions (30 minutes each), "Pompage" technique will be performed by a physical therapist. | Other | Active physical therapy plus manual therapy |
Primary outcome
Changes in neck pain
Time frame: At baseline, 8 weeks, and 6 months.
Visual Analogue Scale (VAS). VAS is a unidimensional measure of pain intensity. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
5 secondary outcomes
Changes in neck disability
Time frame: At baseline, 8 weeks, and 6 months.
Changes in Kinesiophobia/Fear of movement
Time frame: At baseline, 8 weeks, and 6 months.
Changes in Active Cervical Range of Motion
Time frame: At baseline, 8 weeks, and 6 months.
Assessment of the satisfaction for physical therapy
Time frame: At 8 weeks and 6 months.
Assessment of the global perception of improvement on a 7-points Likert Scale
Time frame: At 8 weeks and 6 months.
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 2 Sep 2022.
- 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.
Paolo Pillastrini, Professor principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active physical therapy (including both pain education and home exercises) and Active physical therapy plus manual therapy in people with Non-specific Chronic Neck Pain, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 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 Italy. 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?
Changes in neck pain (time frame: At baseline, 8 weeks, and 6 months.). 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 2 Sep 2022.