Neck PainNCT01504698
Manipulative Treatment of Children With Neck and Back Pain
A study testing Advice and exercise-based treatment plus joint manipulation and Advice and exercise-based treatment in people with Neck Pain and Back Pain, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the… Read more about this study
- Who is it for?
- Ages 8 to 15 years
- What is being tested?
- Advice and exercise-based treatment plus joint manipulation and Advice and exercise-based treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Jun 2014
- 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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.
Who cannot join
- If a serious pathology or injury is suspected, the child will be referred to a secondary care sports injury center for diagnostic work-up and/or imaging.
- Handicaps which prevents normal physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade
The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.
Read the detailed description
Parents receive text messages [SMS) on a weekly basis inquiring about the child's musculoskeletal pain as well as amount and types of sport during leisure time the past week. Following a report of pain, the parents will be interviewed by phone by a member of the clinical team, consisting of two licensed physical therapists and two licensed chiropractors, for a thorough description of the complaint. Based on this, the interviewer determines whether the complaint is negligible or whether the child should be seen by a member of the clinical team, in which case the child will be examined at his or her school. At this examination, the child will be evaluated for inclusion and exclusion criteria.
- Being tested
- Advice and exercise-based treatment plus joint manipulation, Advice and exercise-based treatment
- Keywords
- Manipulative treatment, Children, Neck pain, Back pain, Effect, Adolescence, Advise, Exercise
- Medical subject headings
- Neck Pain, Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advice and exercise-based treatment plus joint manipulationProcedure or surgery
The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment plus joint manipulation.The areas and frequency of manipulative treatment will be determined by the chiropractor and will consist of high-velocity, low-amplitude manipulation and/or mobilization to the spine and/or the extremities.
Advice and exercise-based treatmentProcedure or surgery
The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment. However, assisted stretching is not allowed as this will approach mobilization.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with manipulation | Experimental | Not described Receives: Procedure: Advice and exercise-based treatment plus joint manipulation |
| Treatment without manipulation | Active comparator | Not described Receives: Procedure: Advice and exercise-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrences during the follow-up period.
Weekly reports of pain by sms
Measured: 2 1/2 year
Secondary outcomes (4)
Global perceived effect after two weeks
Questionnaire
Measured: 2 weeks
Change in pain intensity (Numerical Rating Scale)
Questionnaire
Measured: After one and two weeks
Average duration of complaint time for each episode
Weekly reports of pain by sms
Measured: Up till 2 1/2 years
Total duration of complaint time during the follow-up period (combination of duration and recurrences)
Measured: 2 1/2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 University of Southern DenmarkThe 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Chiropractors Fund, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt, IMK Foundation, Chiroform
- Responsible party
- Principal investigator, Kristina Boe Dissing, University of Southern Denmark
- Investigators
- Niels Wedderkopp, Ph.D., Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504698
- Sponsor's protocol ID
- CVKS-20110042
- Status last verified
- May 2015
- First submitted
- 3 Jan 2012
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dissing KB, Vach W, Hartvigsen J, Wedderkopp N, Hestbaek L. Potential treatment effect modifiers for manipulative therapy for children complaining of spinal pain.Secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2019 Dec 10;27:59. doi: 10.1186/s12998-019-0282-7. eCollection 2019.
PubMed 31827767Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. Conservative care with or without manipulative therapy in the management of back and/or neck pain in Danish children aged 9-15: a randomised controlled trial nested in a school-based cohort. BMJ Open. 2018 Sep 10;8(9):e021358. doi: 10.1136/bmjopen-2017-021358.
PubMed 30206079Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. Conservative care with or without manipulative therapy in the management of back and neck pain in Danish children aged 9-15. Study protocol for a randomized controlled trial. Chiropr Man Therap. 2016 Jan 28;24:5. doi: 10.1186/s12998-016-0086-y. eCollection 2016.
PubMed 26823970
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade
- ClinicalTrials.gov ID
- NCT01504698
- Acronym / sponsor ID
- CVKS-20110042
- Keywords
- Manipulative treatment, Children, Neck pain, Back pain, Effect, Adolescence, Advise, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Chiropractors Fund, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt, IMK Foundation, Chiroform
- Study start
- Feb 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 5 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.
Detailed description
Parents receive text messages [SMS) on a weekly basis inquiring about the child's musculoskeletal pain as well as amount and types of sport during leisure time the past week. Following a report of pain, the parents will be interviewed by phone by a member of the clinical team, consisting of two licensed physical therapists and two licensed chiropractors, for a thorough description of the complaint. Based on this, the interviewer determines whether the complaint is negligible or whether the child should be seen by a member of the clinical team, in which case the child will be examined at his or her school. At this examination, the child will be evaluated for inclusion and exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with manipulation | Experimental | Procedure: Advice and exercise-based treatment plus joint manipulation |
| Treatment without manipulation | Active comparator | Procedure: Advice and exercise-based treatment |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.
Key exclusion criteria (2 listed)
- If a serious pathology or injury is suspected, the child will be referred to a secondary care sports injury center for diagnostic work-up and/or imaging.
- Handicaps which prevents normal physical activity.
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 |
|---|---|---|
| Advice and exercise-based treatment plus joint manipulationThe treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment plus joint manipulation.The areas and frequency of manipulative treatment will be determined by the chiropractor and will consist of high-velocity, low-amplitude manipulation and/or mobilization to the spine and/or the extremities. | Procedure or surgery | Treatment with manipulation |
| Advice and exercise-based treatmentThe treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment. However, assisted stretching is not allowed as this will approach mobilization. | Procedure or surgery | Treatment without manipulation |
Primary outcome
Number of recurrences during the follow-up period.
Time frame: 2 1/2 year
Weekly reports of pain by sms
4 secondary outcomes
Global perceived effect after two weeks
Time frame: 2 weeks
Change in pain intensity (Numerical Rating Scale)
Time frame: After one and two weeks
Average duration of complaint time for each episode
Time frame: Up till 2 1/2 years
Total duration of complaint time during the follow-up period (combination of duration and recurrences)
Time frame: 2 1/2 year
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 May 2015.
- Derived from this study: PubMed 31827767Dissing KB, Vach W, Hartvigsen J, Wedderkopp N, Hestbaek L. Potential treatment effect modifiers for manipulative therapy for children complaining of spinal pain.Secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2019 Dec 10;27:59. doi: 10.1186/s12998-019-0282-7. eCollection 2019.
- Derived from this study: PubMed 30206079Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. Conservative care with or without manipulative therapy in the management of back and/or neck pain in Danish children aged 9-15: a randomised controlled trial nested in a school-based cohort. BMJ Open. 2018 Sep 10;8(9):e021358. doi: 10.1136/bmjopen-2017-021358.
- Derived from this study: PubMed 26823970Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. Conservative care with or without manipulative therapy in the management of back and neck pain in Danish children aged 9-15. Study protocol for a randomized controlled trial. Chiropr Man Therap. 2016 Jan 28;24:5. doi: 10.1186/s12998-016-0086-y. eCollection 2016.
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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.
Niels Wedderkopp, Ph.D. study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advice and exercise-based treatment plus joint manipulation and Advice and exercise-based treatment in people with Neck Pain and Back Pain, run by University of Southern Denmark at 1 site in Denmark.
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 2 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 May 2015. 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 Denmark. 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?
Number of recurrences during the follow-up period. (time frame: 2 1/2 year). 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 NCT01504698, which also lists 3 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 May 2015.