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Cervical DystoniaNCT02420106

Effect of Osteopathic Manipulative Medicine on Motor Function and Quality of Life in Cervical Dystonia

A study testing Osteopathic Manipulative Medicine in people with Cervical Dystonia, run by New York Institute of Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used alone or in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical (neck) dystonia. Read more about this study

Who is it for?
Ages 2 to 100 years
Conditions the study is for
Cervical Dystonia
What is being tested?
Osteopathic Manipulative Medicine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Feb 2014to Feb 2019
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 2 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • clinical diagnosis of cervical dystonia or spasmodic torticollis
  • ages 2-100

Who cannot join

  • no clinical diagnosis of cervical dystonia or spasmodic torticollis
  • symptoms beginning over the age of 40
  • pregnant women are excluded from Aim 2

Trial locations and contacts

1 site in 1 country.

United States1 site
  • New York Institute of Technology

    Old Westbury, New York, 11568

Other trials in United States

About this study

The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used alone or in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical (neck) dystonia.

Read the detailed description

Cervical dystonia, also called spasmodic torticollis, is a type of neurological disorder characterized by spastic muscles in the neck that is largely underdiagnosed despite its progression to disability during midlife. Cervical dystonia occurs in at least 0.390% of the United States population in 2007 (390 per 100,000). Symptoms commonly include stiffness, pain, headaches, difficulty swallowing, fatigue, and difficulty walking. The current standard treatment is intramuscular botulinum toxin injection every 90 days. The effect of the botulinum toxin increases gradually, and then it decreases until there is little to no effect at 90 days post-injection. The purpose of the proposed research is to determine if Osteopathic manipulative medicine (OMM) used in combination with the standard treatment of botulinum toxin intramuscular injections improves motor function and quality of life amongst people with cervical dystonia.

The investigators propose to use Vicon 3-dimensional gait and posture analysis to determine the biomechanics of subjects with primary cervical dystonia to compare with full body complaints from a standard spasmodic torticollis/cervical dystonia questionnaire as well as the osteopathic structural exam. These measures will be assessed before and after four OMM treatments. In addition, the investigators propose to use osteopathic manual medicine along with botulinum toxin injection to improve the subjects' pain and motor function as evaluated by Vicon 3-dimensional gait and posture analysis and questionnaire regarding quality of life. Preliminary case reports suggest that Osteopathic manipulative medicine without botulinum toxin injections improved pain, posture, gait, and quality of life in four adult subjects as well as improved head tilt in two children (two- and five-years old). The central hypothesis is that osteopathic manual medicine will significantly improve the range of motion, motor function, and quality of life of subjects with primary cervical dystonia.

Aims:

Aim I. To determine 3-Dimensional gait and posture biomechanics of subjects with untreated primary cervical dystonia while walking, and to investigate the effectiveness of OMM in treating abnormal biomechanics in these subjects.

Hypothesis I: People with cervical dystonia have similar abnormalities in posture and structural exam that significantly alters their gait and full body motor function that can be significantly improved with OMM.

Experimental approach: Motor function will be assessed by Vicon 3-Dimensional analysis using 34 of the subjects while walking will depict stride length and arm swing on each side of the body as well as the posture of the shoulder and pelvic girdle with reference to the coronal, transverse, and sagittal planes. Quality of life will be assessed by the Cervical Dystonia Impact Profile (CDIP)-58 questionaire. Four weekly OMM diagnosis and treatment will be done, and then, motor function and quality of life will be reassessed. Total participation in the study is expected to last for 5-7 weeks.

Expected outcomes: The spasticity in the neck will affect motor function of the whole body. There will be decreased stride length and arm swing on the side of the body with the neck muscle spasm. The shoulder girdle and pelvis will be continuously rotated around a vertical axis the same direction as the head in reference to the feet and direction of walking. The shoulder and pelvic girdles will be tilted such that they are closer together on one side than the other side due to side-bending of the torso. We also expect that there will be an indirect relationship between age and motor function. OMM is expected to significantly improve motor function and quality of life.

Significance: The impact of the neck muscle spasticity on full body biomechanics of subjects with primary cervical dystonia is not well understood, and the results can be used to improve assessment of function as well as management of the disorder.

Aim II. To determine whether osteopathic manual medicine used during the first four weeks following botulinum toxin intramuscular injection will significantly improve the joint range of motion, motor function, and quality of life of subjects with primary cervical dystonia .

Hypothesis II: Osteopathic manual medicine will improve the range of motion of the neck, symmetry of posture and gait, and quality of life of subjects with primary cervical dystonia.

Experimental approach: Subjects being treated with botulinum toxin injections will be evaluated with a standard spasmodic torticollis form (to be filled out by physician), cervical dystonia questionnaire regarding quality of life, and Vicon 3-Dimensional gait and posture analysis before and after four weekly treatments with OMM (n≥8) for comparison with subjects in a no-OMM control condition (n≥ 8).

Expected outcomes: Subjects will have improved quality of life in regard to head and neck symptoms, pain and discomfort, upper limb activities, walking, sleep, annoyance, mood, and psychosocial functioning. Subjects will have improved joint range of motion and motor function.

Significance: Although physicians specializing in osteopathic manual medicine treat patients with various types of dystonia, the effectiveness of osteopathic manual medicine in treating primary cervical dystonia is not established, and thus, osteopathic manual medicine is not recognized or recommended as adjunctive therapy. The botulinum toxin is injected into spastic neck muscles. However, there is no adjunctive procedure recommended for treating the rest of the symptoms associated with the illness. 3-dimensional characterization of motor function has been used in children with cerebral palsy and generalized dystonia before and after surgical intervention, and using a similar method may demonstrate how OMM can prevent people from becoming disabled.

Being tested
Osteopathic Manipulative Medicine
Keywords
cervical dystonia, neck pain, OMM, spasmodic torticollis
Medical subject headings
Torticollis, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathic Manipulative MedicineProcedure or surgery

    Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.

Study groups in NCT02420106
Study groupRoleWhat they receive
OMM aloneActive comparatorSubjects who are not receiving botulinum treatment consenting to Osteopathic Manipulative Medicine intervention
Receives: Procedure: Osteopathic Manipulative Medicine
OMM plus BotulinumActive comparatorSubjects who are receiving botulinum treatment and will have osteopathic manipulative medicine intervention.
Receives: Procedure: Osteopathic Manipulative Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Motor Function

    Motor function will be assessed by Vicon 3-Dimensional analysis of the subjects' biomechanics while walking and will depict stride length and arm swing on each side of the body as well as the posture of the shoulder and pelvic girdle with reference to the coronal, transverse and sagittal planes.

    Measured: baseline and 5 weeks

Secondary outcomes (1)
  1. Change in Quality of Life

    Quality of Life will be assessed by the CDIP-58 questionnaire

    Measured: baseline and 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02420106
Sponsor's protocol ID
BHS-983
Status last verified
Jul 2019
First submitted
18 Feb 2014
Last updated
2 Jul 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic Manipulative Medicine in people with Cervical Dystonia, run by New York Institute of Technology at 1 site in United States.

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 3 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 Jul 2019. 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 United States. 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 Motor Function (time frame: baseline and 5 weeks). 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 Jul 2019; AzTrials last refreshed its copy on 1 Nov 2026.

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