Chronic Neck PainNCT05255055
Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain
A study testing Physical Therapy in people with Chronic Neck Pain, run by University of Jaén at 1 site in Spain.
Trial summary
It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jan 2022to 23 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonspecific cervical pain of more than 12 weeks of evolution.
- Over 18 years.
Who cannot join
- Oncological processes.
- Pregnancy.
- Infectious diseases.
- Degenerative diseases.
- Fibromyalgia.
- Previous spinal surgeries.
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- Previous traumatic events.
- Hernias and/or cervical protrusions.
- Neurological processes.
- Current treatment for cervical pain.
- Neuropathic characteristics pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain - Randomized Clinical Trial
It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. The efficacy of combining manual therapy and therapeutic exercise for the treatment of this pathology has been demonstrated a lot of times. However, no conclusive studies have been found that compare the isolated application of both treatments, thus being an important focus of action and research.
The main objective of the study is to check if the treatment with therapeutic exercise is better than manual therapy in the improvement of the disability in patients with chronic neck pain.
Read more
A randomized, controlled, monocentric, parallel and single-blind clinical trial will be carried out.
The simple will be obtained from the population over 18 years old with chronic neck pain of more than 12 weeks of evolution and will be those who meet the inclusion and exclusion criteria.
The patients will be randomly divided into 2 intervention groups, in one of the groups will be applied a manual therapy session of about 30 minutes once a week for 4 weeks. In the other group it will be delivered and explained to the patients, a home therapeutic exercise program that will be carried out on alternate days for 4 weeks.
- Conditions
- Chronic Neck Pain
- Being tested
- Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
A manual therapy protocol and a therapeutic exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Group | Experimental | Manipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week. Receives: Other: Physical Therapy |
| Therapeutic Exercise Group | Experimental | Recruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index
Measured: Three months
Secondary outcomes (5)
Visual Analog Scale
Measured: Three months
Pressure Pain Threshold
Measured: Three months
Life Quality SF-12
Measured: Three months
Kinesiophobia TAMPA Scale
Measured: Three months
Beck Depression Inventory II
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start12 Jan 2022
- Primary completion22 Sep 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255055
- Sponsor's protocol ID
- UAH/2022/01
- Status last verified
- Dec 2022
- First submitted
- 20 Jan 2022
- Last updated
- 28 Dec 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 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05255055
- Acronym / sponsor ID
- UAH/2022/01
- Conditions
- Chronic Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 24 Feb 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.
It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. The efficacy of combining manual therapy and therapeutic exercise for the treatment of this pathology has been demonstrated a lot of times. However, no conclusive studies have been found that compare the isolated application of both treatments, thus being an important focus of action and research.
The main objective of the study is to check if the treatment with therapeutic exercise is better than manual therapy in the improvement of the disability in patients with chronic neck pain.
A randomized, controlled, monocentric, parallel and single-blind clinical trial will be carried out.
The simple will be obtained from the population over 18 years old with chronic neck pain of more than 12 weeks of evolution and will be those who meet the inclusion and exclusion criteria.
The patients will be randomly divided into 2 intervention groups, in one of the groups will be applied a manual therapy session of about 30 minutes once a week for 4 weeks. In the other group it will be delivered and explained to the patients, a home therapeutic exercise program that will be carried out on alternate days for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Group | Experimental | Other: Physical TherapyManipulation of the high dorsal region in extension. Cervical mobilizations. Massage therapy. Suboccipital inhibition. Once a week. |
| Therapeutic Exercise Group | Experimental | Other: Physical TherapyRecruitment and strengthening of the cervical flexors. Isometric cervical exercises with self-resistance. Shoulder girdle strengthening exercise. Alternating days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nonspecific cervical pain of more than 12 weeks of evolution.
- Over 18 years.
Key exclusion criteria (11 listed)
- Oncological processes.
- Pregnancy.
- Infectious diseases.
- Degenerative diseases.
- Fibromyalgia.
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 |
|---|---|---|
| Physical TherapyA manual therapy protocol and a therapeutic exercise protocol | Other | Manual Therapy Group, Therapeutic Exercise Group |
Primary outcome
Neck Disability Index
Time frame: Three months
5 secondary outcomes
Visual Analog Scale
Time frame: Three months
Pressure Pain Threshold
Time frame: Three months
Life Quality SF-12
Time frame: Three months
Kinesiophobia TAMPA Scale
Time frame: Three months
Beck Depression Inventory II
Time frame: Three 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 28 Dec 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.
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 Physical Therapy in people with Chronic Neck Pain, run by University of Jaén 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 11 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 28 Dec 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?
Neck Disability Index (time frame: Three 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 28 Dec 2022.