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Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia

ConditionsFibromyalgiaPregabalinPain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common.Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.we carried out an open-label clinical trial in order to evaluate the efficacy and safety of combined treatment with tizanidine and pregabalin for pain in FM.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.Aged 18-65 years. 2.Fulfill the 2016 updated American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.

Disqualifiers

1.Presence of a painful condition, including inflammatory rheumatic disease, more than 50% as severe as but distinct from fibromyalgia.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregabalin

    Drug

    The patients receive open-label pregabalin (Pfizer Pharmaceutical Co. Ltd, New York) titration therapy. In the first week, patients receive the starting dose of 150 mg/day (75 mg twice daily) escalated, based on efficacy and tolerability, at weekly visits to increase by 150 mg per week. A final dose of 450 mg/day (225 mg twice daily). However, during this flexible dose titration, the final dose arrived at during the maximal tolerated dose week (week 3 of the treatment period) could be lower than the ceiling dose of 450 mg, if the patient could not tolerate the dose increase, it is reduce to the pre-escalation dose. Thus, this trial will not use a forced titration to the ceiling dose of 450 mg/day.

  • Pregabalin with tizanidine

    Drug

    All patients receive tizanidine in an open-label fashion. The tizanidine dose is slowly escalated over approximately 3 weeks. The initial dosage is 2 mg/d at bedtime. The dosage is increased by 2 mg every 2 days in the first week in 3 divided doses. The dosage is then increased more rapidly by 4 mg every 2 days in the second week divided 3 times a day. During the third week, the dose was further escalated by 6 mg every 2 days to a maximum of 24 mg/d divided 3 times a day. If a patient could not tolerate a particular current specific dosage increase because of side effects, he or she is maintain at the previous dosage during the trial period. The patients receive open-label pregabalin (Pfizer Pharmaceutical Co. Ltd, New York) titration therapy. In the first week, patients receive the starting dose of 150 mg/day (75 mg twice daily) escalated, based on efficacy and tolerability, at weekly visits to increase by 150 mg per week. A final dose of 450 mg/day (225 mg twice daily).

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Pregabalin monotherapy groupActive comparator 1 intervention
Group B: Pregabalin with tizanidine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average pain intensity

The primary outcome is change from baseline to 12 weeks of treatment in average pain intensity during the last 7 days on an 11-point rating scale (ranging from 0 = "no pain" to 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised (FIQR)

Time frame
baseline , 12 weeks

Secondary outcomes

1

Fibromyalgia Impact Questionnaire Revised

The FIQR is a well-validated multidimensional instrument that measures participant-rated overall severity of fibromyalgia, including intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being. Each item is standardized on a scale ranging from 0 to 10, with lower scores indicating more improvement or less negative impact. In addition, FIQR is also assessed weekly during the intervention period for all groups of participants as well as at the 24-week time points as secondary outcomes.

Time frame
weekly(from baseline to 24 weeks)
2

Medical Outcome Study Short Form 36 Health Survey (SF-36)

Health Related Quality of Life assessments are made using the Medical Outcome Study Short Form 36 Health Survey (SF-36). The SF-36 is a self-administered, 36-item questionnaire that assesses the concepts of physical functioning, role limitations due to physical problems, social function, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions. Summary scores include physical function, mental function, and combined total function. Scores range from 0 to 100, with higher scores indicating better health status.

Time frame
baseline , 4, 8, 12, 16, 20, and 24 weeks
3

The Patient's Global Assessment

The Patient's Global Assessment (Global Visual Analogue Scale) is a visual analogue scale that measures the level of fibromyalgia severity on a 10-point scale with 10 reflecting the most extreme severity and 0 reflecting no severity.

Time frame
baseline , 4, 8, 12, 16, 20, and 24 weeks
4

The Beck II Depression Inventory

The Beck II Depression Inventory (BDI) is a 21-question, validated, self-report instrument that measures the severity of depressive symptoms (each scored 0-3, sum=0-63). Higher scores reflect a greater degree of symptom severity. The total questionnaire score ranges from 0 to 63 points. The result is interpreted by the usual classifications as follows: no depression (0-9 points), mild depression (10-18 points), moderate depression (19-29 points) and severe depression (\>30 points).

Time frame
baseline , 4, 8, 12, 16, 20, and 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Sichuan Provincial People's Hospital

Collaborator

Source ClinicalTrials.gov

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