Subacute Cervical PainNCT00282958
The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
A study testing Botulinum Toxin type a (Botox) in people with Subacute Cervical Pain and Subacute Upper Back Pain, run by Palo Alto Veterans Institute for Research.
Trial summary
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Subacute Cervical Pain, Subacute Upper Back Pain
- What is being tested?
- Botulinum Toxin type a (Botox)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jul 2006
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female 18 y/o or greater,
- Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
- VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
- If female or child bearing potential, concurrent use of a reliable method of contraception.
Who cannot join
- Known allergy or sensitivity to Botulinum toxin type A.
- Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
- Pregnancy, breast feeding, or planned pregnancy
- Acute or operative pathology on cervical MRI
- History of treatment for gatro-esophageal reflux disease
- Abnormal finding on 3-oz water swallowing test on the initial screening visit
About this study
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.
Read the detailed description
Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study.
A total of 30 subjects with subacute cervical/upper back pain will be recruited. If patients are qualified as participants and agreed to participate in the study by signing the consent form, they will be randomized into either (A) control group (injection of normal saline injection) or (B) study group (injection of BOTOX). The initial history taking step will include medical history including medication and surgery history, duration of pain, pre-injection neck disability index (NDI) and visual analogue scale (VAS) for pain. VAS score will be collected for 4 weeks before injection to ensure stable VAS, otherwise medical records will be reviewed to ensure stable feature of pain. Short Form (SF) -36 Health Survey will be used to assess functional status, and the Beck Depression Inventory (BDI) will be applied to assess psychological aspect. Physical examination will be performed to determine the most tender cervical/ upper back muscles, and rule out operative condition. A simple swallowing test (3-oz water swallowing test) will be applied for dysphagia screening.
The patients will be maintained with routine, standardized physical therapy, oral medication, and stretch exercise after the injection. NDI, VAS, and SF-36 questionnaire will be re-collected at 1, 2, 3, 4, and 6 months after the injection session.
- Conditions
- Subacute Cervical Pain, Subacute Upper Back Pain
- Being tested
- Botulinum Toxin type a (Botox)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin type a (Botox)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
NDI, VAS, SF-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startFeb 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute Cervical 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
- Double blind
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- Elaine Date, MD, Principal investigator, VA Palo Alto Health Care SystemHenry Lew, MD, Ph.D, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282958
- Sponsor's protocol ID
- DAT0014
- Status last verified
- Mar 2015
- First submitted
- 25 Jan 2006
- Last updated
- 5 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Use of Botulinum Toxin Type A in Subacute Cervical/Upper Back Pain
- ClinicalTrials.gov ID
- NCT00282958
- Acronym / sponsor ID
- DAT0014
- Conditions
- Subacute Cervical Pain, Subacute Upper Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Feb 2003
- Study completion
- Jul 2006
- First posted
- 27 Jan 2006 (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.
To determine the therapeutic efficacy of Botox not only for chronic cervical/upper back pain but also for subacute pain.
Detailed description
Subjects diagnosed with subacute (2-6 months post-onset) bilateral cervical/ upper back pain will be recruited in this double-blind control study.
A total of 30 subjects with subacute cervical/upper back pain will be recruited. If patients are qualified as participants and agreed to participate in the study by signing the consent form, they will be randomized into either (A) control group (injection of normal saline injection) or (B) study group (injection of BOTOX). The initial history taking step will include medical history including medication and surgery history, duration of pain, pre-injection neck disability index (NDI) and visual analogue scale (VAS) for pain. VAS score will be collected for 4 weeks before injection to ensure stable VAS, otherwise medical records will be reviewed to ensure stable feature of pain. Short Form (SF) -36 Health Survey will be used to assess functional status, and the Beck Depression Inventory (BDI) will be applied to assess psychological aspect. Physical examination will be performed to determine the most tender cervical/ upper back muscles, and rule out operative condition. A simple swallowing test (3-oz water swallowing test) will be applied for dysphagia screening.
The patients will be maintained with routine, standardized physical therapy, oral medication, and stretch exercise after the injection. NDI, VAS, and SF-36 questionnaire will be re-collected at 1, 2, 3, 4, and 6 months after the injection session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 y/o or greater,
- Subacute bilateral cervical/ upper back pain, pain of longer than 2 months and shorter than 6 months duration,
- VAS pain score of 5 or greater for the cervical/ upper back pain for 4 week period before injection,
- If female or child bearing potential, concurrent use of a reliable method of contraception.
Key exclusion criteria (7 listed)
- Known allergy or sensitivity to Botulinum toxin type A.
- Any medical condition that may put the subject at increased risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
- Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function
- Pregnancy, breast feeding, or planned pregnancy
- Acute or operative pathology on cervical MRI
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 |
|---|---|---|
| Botulinum Toxin type a (Botox) | Drug | – |
Primary outcome
NDI, VAS, SF-36
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 5 Mar 2015.
Related trials for Subacute Cervical Pain
Not yet recruiting
The Effectiveness of Breathing Training in Subacute Neck Pain
Active Cycle of Breathing Technique, Progressive Muscle Relaxation
Recruiting
Effects of Post Isometric Relaxation as Compared to Post Isometric Stretching Muscle Energy Technique in the Management of Neck Pain: a Randomized Controlled Trial
Chronic Neck Pain
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.
Elaine Date, MD principal investigator
VA Palo Alto Health Care System
Henry Lew, MD, Ph.D principal investigator
VA Palo Alto Health Care System
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum Toxin type a (Botox) in people with Subacute Cervical Pain and Subacute Upper Back Pain, run by Palo Alto Veterans Institute for Research.
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 4 inclusion and 7 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
NDI, VAS, SF-36. 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 5 Mar 2015.