Neck PainNCT04856813
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
A study testing Manual therapy active and Manual therapy in people with Neck Pain and Chronic Pain, run by Alexander Achalandabaso at 1 site in Spain.
Trial summary
It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Manual therapy active and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2021to 9 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- accept to participate in the study, through informed consent
- subjects with chronic nonspecific neck pain lasting equal to or more than 3 months
Who cannot join
- Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases.
- Cervical pathology of traumatic origin with less than 6 months of evolution.
- Rheumatic diseases.
- Neck pain with neurological signs such as: radiculopathy and myelopathy.
- Previous surgery of the cervical spine.
- Pregnancy.
Show all 9Show fewer
- Have received physiotherapeutic treatment in the cervical region during the month prior to the inclusion of the study.
- Have the intention of receiving other physiotherapeutic treatments different from the one proposed during the study period.
- Present serious mental disorders.
Trial locations and contacts
1 site in 1 country.
About this study
It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.
Read the detailed description
The study will be divided in two different groups:
- A control group (group A) : they will receive a treatment with manual therapy and physical exercise.
- An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction.
The exercise is compound by a home program of several exercises with diferent difficulties.
The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Manual therapy active, Manual therapy
- Keywords
- neck pain, exercise, Endurance, Training, Intervention
- Medical subject headings
- Neck Pain, Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy activeOther
massage or ischemic compression with active contraction, tha will be isometric or concentric.
Manual therapyOther
massage or isquemic compression without contraction
| Study group | Role | What they receive |
|---|---|---|
| active | Experimental | this is the group that does a treatment with active movement, a program of pain education and a program of home exercise. Receives: Other: Manual therapy active |
| non active | Active comparator | this is the group that does a treatment without active movement, a program of pain education and a program of home exercise. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck disability
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
Measured: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Secondary outcomes (6)
Change in pain perception
Using the Visual Analog Scale (VAS) from 0 to 10
Measured: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Change in Range of motion (ROM)
Using a inclinometer
Measured: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Change in craniocervical flexion
Using the craniocervical flexion test (CCFT) we make a evaluation of the strength of the deep cervical flexor muscles. From 22 to 30 mmHg of preasure.
Measured: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Change in kinesophobia
Using the Tampa Scale for Kinesiophobia-11 (TSK-11), self-report of 17 items that address fear of movement and injury relapse. Four of the items are negatively written and scored inverse (4, 8, 12 and 16). The scores are added together to obtain a total score, with higher values reflecting greater kinesiophobia.
Measured: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Change in Catastrophism
Using the Pain catastrophizing scale from 0 to 56
Measured: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Change in Sleep Quality
Using the Pittsburgh Sleep Quality Index
Measured: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Aug 2021
- Primary completion9 Dec 2021
- Study completion9 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- blind
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexander Achalandabaso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Alexander Achalandabaso, Study director, University of Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856813
- Sponsor's protocol ID
- CEIM/HU/2020/5/055
- Status last verified
- Nov 2022
- First submitted
- 6 Apr 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
- ClinicalTrials.gov ID
- NCT04856813
- Acronym / sponsor ID
- CEIM/HU/2020/5/055
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- neck pain, exercise, Endurance, Training, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Alexander AchalandabasoUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 9 Jul 2022 (actual)
- First posted
- 23 Apr 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.
It is an interventional study that proves the eficacy of the manual therapy with active manual therapy and combined with exercise in cervical pain.
Detailed description
The study will be divided in two different groups:
- A control group (group A) : they will receive a treatment with manual therapy and physical exercise.
- An experimental group (group B) : they will receive the previous treatment, but also the pacient's do active muscle active contraction.
The exercise is compound by a home program of several exercises with diferent difficulties.
The contraction will consist on a combination of concentric and isometric work. being the patient's pain threshold the one that will guide us to the choice of the predominance of concentric or isometric contraction . Both groups will be joined by a five-minute work on pain education.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- blind
| Arm | Type | Receives |
|---|---|---|
| active | Experimental | Other: Manual therapy activethis is the group that does a treatment with active movement, a program of pain education and a program of home exercise. |
| non active | Active comparator | Other: Manual therapythis is the group that does a treatment without active movement, a program of pain education and a program of home exercise. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- accept to participate in the study, through informed consent
- subjects with chronic nonspecific neck pain lasting equal to or more than 3 months
Key exclusion criteria (9 listed)
- Present neck pain caused by serious pathology such as: inflammatory, congenital, infectious, metabolic and neoplastic diseases.
- Cervical pathology of traumatic origin with less than 6 months of evolution.
- Rheumatic diseases.
- Neck pain with neurological signs such as: radiculopathy and myelopathy.
- Previous surgery of the cervical spine.
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 |
|---|---|---|
| Manual therapy activemassage or ischemic compression with active contraction, tha will be isometric or concentric. | Other | active |
| Manual therapymassage or isquemic compression without contraction | Other | non active |
Primary outcome
Change in Neck disability
Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Using the Neck Disability Index (NDI). It is made up of 10 items and each item is scored on a 6-point Likert scale (0 to 5), leading to a total score ranging from 0 to 50 (0 to 4 = no disability; 5 to 14 = mild disability; 15 to 24 = moderate disability; 25 to 34 = severe disability; and 35 to 50 = complete disability).
6 secondary outcomes
Change in pain perception
Time frame: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Change in Range of motion (ROM)
Time frame: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Change in craniocervical flexion
Time frame: Baseline, 1 month (primary timepoint) and 2 months after intervention commencement.
Change in kinesophobia
Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
Change in Catastrophism
Time frame: Baseline, 1 month (primary timepoint), 2 months and 5 months after intervention commencement.
Change in Sleep Quality
Time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.
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 Nov 2022.
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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.
Alexander Achalandabaso study director
University of Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy active and Manual therapy in people with Neck Pain and Chronic Pain, run by Alexander Achalandabaso at 1 site in Spain.
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 9 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 Nov 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 Spain. 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?
Change in Neck disability (time frame: Baseline, 1 month (primary timepoint) , 2 months and 5 months after intervention commencement.). 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 Nov 2022.